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<h3>Job Description</h3>
Job Description
Position Summary
The Quality Systems Director is responsible for developing, implementing, and maintaining a robust Quality Management System (QMS) to ensure compliance with cGMP regulations (21 CFR Parts 210 &amp; 211), FDA aseptic processing guidelines, and EU GMP Annex 1.
Duties 
and Responsibilities
<ul>
<li>Lead the Quality Systems division within the QA Department, supporting the development, clinical, and commercial activities of pharmaceutical and biotech companies.</li>
<li>Oversee and maintain Quality Systems to ensure compliance with regulatory requirements. Key areas of focus include Document Control, Training Programs, Complaint Handling, Supplier Management, and Quality Management Systems (QMS).</li>
<li>Manage the Complaint Program, ensuring non-conformances are properly documented, investigated, and resolved through effective root cause analysis and corrective/preventive actions.</li>
<li>Oversee the Vendor Approval Program, ensuring outside vendors and suppliers meet compliance requirements through qualification and routine audits.</li>
<li>Develop and maintain Quality Agreements with clients and critical suppliers to ensure alignment on compliance and quality expectations.</li>
<li>Lead the Client Change Notification Program, ensuring timely and accurate communication of company changes to SSM clients.</li>
<li>Oversee the Client Audit Program, collaborating with cross-functional teams (Manufacturing, Quality Control, Warehouse, and Engineering) to maintain a continuous state of audit readiness.</li>
<li>Support regulatory inspections, working closely with the Head of Quality to prepare for inspections and respond to regulatory agency observations and requests.</li>
<li>Prepare and report quality metrics, providing actionable insights to senior leadership for decision-making.</li>
<li>Provide client support for ANDA/NDA submissions and pre-PAI/PLI inspections, ensuring compliance with regulatory expectations.</li>
<li>Conduct Annual Product Reviews (APRs) for client products, analyzing trends and ensuring ongoing compliance.</li>
<li>Stay current with evolving FDA (21 CFR 210/211), EU GMP, and industry regulations, advising executive management on necessary updates to the Quality Management System (QMS) to maintain compliance and drive improvements.</li>
<li>Foster strong cross-functional collaboration and ensure cGMP requirements and quality standards are understood and upheld across the organization.</li>
<li>Represent Quality Assurance at senior management, project, board, and review meetings, providing strategic input and leadership on quality initiatives.</li>
</ul>
Regulatory Responsibilities 
Position requires a broad knowledge of life sciences as they relate to the manufacture and testing of pharmaceutical drug products. Thorough knowledge of FDA / EU regulations, particularly as they relate to 21 CFR 210/211 and GMP manufacturing.
Supervisory Responsibilities
<ul>
<li>Provide leadership in daily quality operations, and have employees incorporate QA compliance practices into their daily routines. </li>
</ul>
Experience
<ul>
<li>Minimum of ten (10) years of pharmaceutical experience in a quality role</li>
<li>Minimum of five (5) years in a supervisor/managerial role </li>
</ul>
Education
<ul>
<li>Minimum of a Bachelor of Science Degree</li>
<li>Master’s Degree preferred </li>
<li>Auditor certification from an accredited institute preferred </li>
</ul>
Knowledge, Skills &amp; Abilities
<ul>
<li>In-depth knowledge in current Good Manufacturing Practices (cGMP), analytical chemistry, FDA requirements, ICH guidelines, USP methodology, and EU requirements as they pertain to the pharmaceutical industry.</li>
<li>Thorough knowledge of aseptic manufacturing processes.</li>
<li>ISO requirements and medical device experience is preferred.</li>
<li>Able to travel to vendors, customers and/or other contractual facilities as needed.</li>
<li>Technical writing and strong complex problem-solving skills.</li>
<li>Ability to effectively and clearly communicate, both written and verbally in English.</li>
<li>Detailed oriented</li>
</ul>
Physical Requirements

<ul>
<li>Ability to sit for prolonged periods of time</li>
<li>Ability to lift up to 10lbs</li>
<li>Ability to stand for prolong periods of time</li>
</ul>

Director of Quality Systems

<h3>Job Description</h3>
Job Description
Position Summary: Responsible for the development, implementation and evaluation of overall quality and performance improvement plans, projects (PIPs) and initiatives at VNA Care. Works collaboratively with the Quality Improvement Team to drive efficacy in clinical documentation, quality metrics, patient outcomes and reimbursement.
Reports to: Vice President, Organizational Excellence/Chief Compliance Officer
Functions &amp; Responsibilities:
<ul>
<li>Maintains current knowledge of home health compliance and regulatory requirements, including, but not limited to, completion of OASIS, PDGM, publicly reported quality metrics, patient outcomes and documentation requirements for efficient and accurate reimbursement of patient care.</li>
<li>Reviews clinical documentation to ensure it meets education standards, state and federal regulations and best practice standards. Conducts quality and compliance audits as directed.</li>
<li>Utilizes HCHB back-office (R2) application in order to support all aspects of revenue cycle workflow efficiency and documentation accuracy, including but not limited to, review/process, OASIS/coding, Plan of Care, Face to Face, Physician/Provider Medical Orders, Visit Documentation and Billing/Claims.</li>
<li>Reviews clinical documentation and compiles data/trends for improvement in key performance and quality metrics. Provides feedback to Clinical Operations and Clinical Managers on areas for clinical documentation and/or quality metrics improvement.</li>
<li>Provides real-time feedback to the Education Team on recommended areas for education focus to improve clinical documentation and OASIS completion and to support accurate quality metrics and improved patient outcomes.</li>
<li>Serves as a subject matter expert (SME) for QI activities collaborating closely with Quality Improvement, Clinical Operations, Patient Admissions and revenue cycle departments to develop a continuous quality review process to optimize efficiency, improve documentation accuracy and promote best practices.</li>
<li>Participates in VNA Care task forces/committees established for organizational improvements as appropriate or as requested. Demonstrates professional growth and development through continuing education and review of current literature.</li>
<li>Upholds the compliance objectives and policies and procedures of the Foundation and Subsidiaries.</li>
<li>Performs other related duties of a similar nature and complexity as directed.</li>
</ul>
Skills and Knowledge:
Education
<ul>
<li>Bachelor of Science Degree in Nursing from an accredited program.</li>
<li>OASIS Certification required.</li>
<li>Diagnosis Coding Certification preferred.</li>
<li>Licensed to practice in Massachusetts.</li>
</ul>
Experience
<ul>
<li>Minimum 3 years recent experience in a related role with a certified home health organization (i.e. clinical operations, quality review, performance improvement and/or OASIS/coding review).</li>
<li>Strong analytical, assessment and problem-solving skills. Ability to read, interpret and apply written regulations, guidelines and other materials.</li>
<li>Strong interpersonal skills, including the ability to establish and maintain effective working relationships with individual at all levels.</li>
</ul>

Home Health RN Quality Improvement Specialist

<h3>Job Description</h3>
Job DescriptionQuality/Risk Director Career Opportunity Highly regarded and valued for your Quality/Risk Director expertise Are you seeking a career that not only utilizes your skills but also aligns with your personal values, providing a profound sense of belonging and the opportunity to make a meaningful difference in patients' lives? Look no further than Encompass Health, the nation's leader in in-patient rehabilitation care. As a Quality/Risk Director, you will oversee a hospital-wide quality management program, collaborating with various stakeholders to monitor and enhance the quality of patient care services. Join a team that values collaboration, support, and inclusivity, and embark on a rewarding career close to home and close to your heart, complete with access to cutting-edge equipment and technology and a comprehensive benefits package from day one. A Glimpse into Our World At Encompass Health, you'll experience the difference the moment you become a part of our team. Being at Encompass Health means aligning with a rapidly growing national inpatient rehabilitation leader. We take pride in the growth opportunities we offer and how our team unites for the greater good of our patients. Our achievements include being named one of the "World's Most Admired Companies" and receiving the Fortune 100 Best Companies to Work For® Award, among other accolades, which is nothing short of amazing. Starting Perks and Benefits At Encompass Health, we are committed to creating a supportive, inclusive, and caring environment where you can thrive. From day one, you will have access to: 
<ul>
<li>Affordable medical, dental, and vision plans for both full-time and part-time employees and their families.</li>
<li>Generous paid time off that accrues over time.</li>
<li>Opportunities for tuition reimbursement and continuing education.</li>
<li>Company-matching 401(k) and employee stock purchase plans.</li>
<li>Flexible spending and health savings accounts.</li>
<li>A vibrant community of individuals passionate about the work they do!</li>
</ul>
 Become the Quality/Risk Director you've always aspired to be 
<ul>
<li>Ensure compliance with regulatory agencies, accrediting bodies, corporate and hospital policies, and procedures. Develop, implement, and maintain quality assessment and improvement programs.</li>
<li>Assess compliance with federal, state, and industry regulatory and accreditation standards, facilitating processes to remediate and/or maintain compliance. Provide organizational education related to regulations and standards and coordinate local, state, federal, and accreditation surveys.</li>
<li>Use a variety of applications (including, but not limited to, PatCom, UDS, ORYX, and Press Ganey) to identify improvement opportunities, generate reports, research issues, identify resources, and access external databases.</li>
<li>Ensure the update and maintenance of hospital plans, including the Provision of Care/Scope of Services, Leadership, Information Management, Utilization Review, Infection Control, and Patient Safety plans. Oversee risk management activities, including completion of incident reports, notice of potential claims, corrective action planning, and incident reporting to the Corporate Risk Manager.</li>
<li>Coordinate the review, development, and implementation of hospital policies.</li>
<li>.Communicate and collaborate with other departments to coordinate care and promptly resolve patient concerns or complaints.</li>
<li>Celebrate the accomplishments and successes of our dedicated employees along the way.</li>
</ul>
 Qualifications 
<ul>
<li>A bachelor's degree in healthcare or a related field is preferred.</li>
<li>License or Certification as required by state regulations.</li>
<li>Experience in Quality and/or Risk Management, including primary responsibility for performance improvement activities, regulatory compliance, conflict resolution, leadership, and risk management activities.</li>
</ul>
The Encompass Health Way We proudly set the standard in care by leading with empathy, doing what's right, focusing on the positive, and standing stronger together. Encompass Health is a trusted leader in post-acute care with over 150 nationwide locations and a team of 36,000 exceptional individuals and growing! At Encompass Health, we celebrate and welcome diversity in our inclusive culture. We provide equal employment opportunities regardless of race, ethnicity, gender, sexual orientation, gender identity or expression, religion, national origin, color, creed, age, mental or physical disability, or any other protected classification. We're looking forward to meeting you, and we genuinely mean that. Join us on this remarkable journey!

Director of Quality and Risk

<h3>Job Description</h3>
Job DescriptionSalary: The pay is commensurate with experience 
ABOUT THE ORGANIZATION:
 
AEIS LLC - Atlas Evaluation and Inspection Services is a premier inspection services and materials testing company in the NY Metro area. Our dedicated team takes an interdisciplinary approach to solving complex problems. We are an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, veteran status or another protected category. We are committed to providing a diverse workplace and believe our employees are our greatest asset. This includes people like you! Apply today and join the AEIS family. To learn more about us, visit our website at <a href="http://www.aeis.com" target="_blank">www.aeis.com</a>.
 
Job Summary:
The Construction Quality Manager is Key Personnel. The Quality Manager is expected to inspect the Work at the worksite daily and be responsible for developing and implementing the Quality Plan and for the management and oversight of all quality issues. The Quality Manager shall have demonstrated relevant quality experience, which establishes the candidates experience, with demonstrated experience in the capacity of full time Quality Assurance and/or Quality Control management. The Quality Manager must have at least 10 years of related Quality Management experience. The Quality Manager is preferred to have current certification in Quality Management from the American Society for Quality (ASQ) or a certified ISO-9001 Lead Auditor as recognized by the ANSI-ASQ National Accreditation Board (ANAB).
 
Qualifications:
<ul>
<li>Education:
<ul>
<li>Bachelors degree in Civil Engineering, Construction Management, or a related field.</li>
<li>New York state Professional Engineer (PE) license.</li>
<li>Professional certification inQualityManagementfrom the American Society forQuality (ASQ) or the American Society of Civil Engineers, or other certifications e.g. ISO 9001, Six Sigma (preferred) </li>
</ul>
</li>
<li>Experience:
<ul>
<li>Minimum of 10 years of experience in construction quality management or a related role.</li>
<li>Proven experience in managing quality control on large-scale construction projects.</li>
<li>Experience working on MTA projects.</li>
</ul>
</li>
<li>Skills:
<ul>
<li>Strong understanding of construction processes, materials, and methods.</li>
<li>Knowledge of relevant construction codes, standards, and regulations.</li>
<li>Excellent problem-solving and analytical skills.</li>
<li>Strong leadership and team management abilities.</li>
<li>Proficiency in quality management software and tools.</li>
<li>Effective communication and interpersonal skills.</li>
</ul>
</li>
</ul>
 
Working Conditions:
<ul>
<li>Ability to work on construction sites in various weather conditions.</li>
<li>May require occasional travel to different project sites.</li>
</ul>
 
Location: New York, NY
 
Job Type: Full-time
 
COMPENSATION: Compensation is commensurate with experience in a similar role and includes a comprehensive benefits package. This is a full-time position.
 
Benefits:
<ul>
<li>401(k)</li>
<li>Dental insurance</li>
<li>Health insurance</li>
<li>Paid time off</li>
<li>Professional development assistance</li>
<li>Referral program</li>
<li>Vision insurance</li>
</ul>
 
Schedule:
<ul>
<li>Monday to Friday</li>
<li>Weekends as needed</li>
</ul>

Construction Quality Manager (NYPE)

<h3>Job Description</h3>
Job Description
Top reasons to work for our client:
<ul>
<li>Great team environment!</li>
<li>Manager is well respected by team!</li>
<li>Inclusive Workplace</li>
<li>Awesome career development opportunities!</li>
<li>Competitive Rates</li>
</ul>
Job Type : Full TimeLocation : Nashua, New HampshirePay : Great Pay + Benefits!Job Description What you will be doing:
<ul>
<li>Provide hands-on leadership for sustainable improvements in quality, productivity, and teamwork.</li>
<li>Lead the root cause corrective action process and recommend continuous improvements to production processes.</li>
<li>Handle relevant ISO 9000 and customer audits and activities.</li>
<li>Supervise the Quality Lab, including hiring and training of lab personnel to ensure coverage.</li>
<li>Conduct performance reviews of Quality lab personnel.</li>
<li>Help set, update, and maintain product specifications based on process and test method capabilities.</li>
<li>Approve process and product specification deviations in agreement with team members.</li>
<li>Ensure test methods and training for conducting Quality tests meet all requirements.</li>
<li>Lead problem-solving efforts with the Operations Team to reduce defective product and waste.</li>
<li>Set goals for quality improvements and process specification updates in collaboration with technicians, engineers, production supervisors, and management.</li>
<li>Identify and implement tools to measure, analyze, record, and improve online testing, offline testing, and statistical analysis.</li>
<li>Participate in customer-focused and internal audits.</li>
<li>Maintain proper ISO documentation and updates including instrumentation, audits, safety, and procedures.</li>
<li>Fulfill required customer ISO and related compliance documentation.</li>
<li>Act as a technical liaison for QC, Manufacturing, and management.</li>
<li>Work on lab maintenance and improvement projects in support of goals.</li>
</ul>
Experience you will need:
<ul>
<li>BS degree or an equivalent combination of education and industrial experience.</li>
<li>QC lab experience testing a manufactured product is required.</li>
<li>Ability to qualify and teach the use of physical and analytical test equipment.</li>
<li>Familiarity with standard concepts, practices, and procedures within the Quality discipline.</li>
<li>Experience and/or understanding of ISO-related principles.</li>
</ul>
Our client asked me to submit 3 great people within the next few days. We work directly with the hiring manager and can arrange interviews within a few days #INDEH123

Quality Supervisor #ESF4739

<h3>Job Description</h3>
Manufacturing / Process Engineer - West Bridgewater, MA \n \nMUST HAVE PCB / SMT Experience! \n \nTargeting $100K to $130K, flexible based on experience.&nbsp; \n \nJob Summary: \n \nAn individual contributor whose responsibilities include, but are not limited to design, development, organization, documentation, implementation, and support of printed circuit board assembly processes, box build processes, equipment and materials.&nbsp; Support mechanical designs, tooling and documentation that is used in the assembly of printed circuit boards, box builds, mechanical assemblies and any other products that are assembled in the operation. \n \n \nResponsibilities\n
<ul>\n\t
<li>Design, develops and specs procures; installs, organizes, documents, implements, and sustains equipment and processes that pertain to the assembly of printed circuit boards with thru-hole technology, surface mount technology and/or&nbsp;combinations of both.&nbsp;&nbsp;&nbsp;&nbsp;\n\t</li>
<li>Design, develops and specs, procures; installs, organizes, documents, implements, and sustains equipment and processes that pertain to the encapsulation of printed circuit boards in plastic cases, metal enclosures, conformal coatings and/or potting materials.\n\t</li>
<li>Engineer changes, processes improvements and modifications so as to increase efficiencies, increase yields, guarantee quality, and reduce cost.\n\t</li>
<li>Contribute to personnel that designs, develops, documents, performs and reports on experiments that are geared to resolve problems in the various manufacturing processes pertaining to printed circuit board design, assembly, box builds, mechanical assemblies and any other products that are assembled in the operation.\n\t</li>
<li>Interface with technical and non-technical support personnel from the various internal and external groups that sustain the manufacturing operations.\n\t</li>
<li>Contribute to personnel that generate, document and implement programs used in the automated and semi-automated equipment that pertain to the assembly of printed circuit boards with thru-hole technology, surface mount technology and/or a combination of both.\n\t</li>
<li>Contribute to personnel that provide equipment operators with training on the use of the automated and semi-automated equipment that pertains to the assembly of printed circuit boards with thru-hole technology, surface mount technology and/or a combination of both.\n\t</li>
<li>Contribute to personnel that generate, document, publish, and implement preventative maintenance programs on equipment that pertain to the assembly of printed circuit boards with thru-hole technology, surface mount technology and/or a combination of both. \n</li>
</ul>
 \n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\tAs part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community. 
Why Kelly® Engineering?
 Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world’s most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we’re here to guide you to the next step in your engineering career.\n\t\t\t \n\t\t\t \n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t
About Kelly
 Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year. Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. \n\t\t\t \n\t\t\t

Manufacturing / Process Engineer

<h3>Job Description</h3>
Job Description
Job Title: Sr. Manager, Quality and Regulatory Assurance
Reports To: VP, Quality
Position Location: Franklin, MA
FLSA Status (Exempt/Non-Exempt): FLSA Status: Exempt
Position Summary: 
The Senior Manager, Quality and Regulatory Assurance position is responsible for the implementation and execution of the Quality program for all products, raw materials, processes and services. This position will work closely with all areas of the company; primarily Channel Management, Purchasing, Receiving, Manufacturing, Shipping, Sales and Customer Support. In addition, this position works closely on the front line with our customers to ensure that our outstanding quality standards and costing initiatives are upheld.
The role will handle quality issues either directly with our customers or through our channel management team. The role is responsible for overall tracking and interpreting statistical data relating to quality; recommends changes in standards, processes, equipment and materials to facilitate work and maintain quality. The role also interacts with supervisors to determine and resolve quality related issues.
Key Responsibilities: 
<ul>
<li>Provide strategic leadership for the Quality Control Program to ensure all products, raw materials, processes and services meet the Company’s exceptionally high-quality standards</li>
<li>Ensure company compliance with accredited quality systems: 21 CFR part 820, ISO 13485, and applicable EU, UK, and Australian requirements</li>
<li>Continue to strategically evolve company quality system as well as transition system with revisions of standards</li>
<li>Acts as Management Representative and performs all duties and tasks associated with that designation. Acts a PRRC for European compliance.</li>
<li>Lead company audits either by accreditation bodies or by customers</li>
<li>Work with the appropriate teams to ensure proper action is taken and that the steps are initiated to avoid repeat errors.</li>
<li>Maintain documentation and revision level of quality documentation for all products or services</li>
<li>Maintain and communicate all quality data to department managers for problem identification, resolution, loss reporting</li>
<li>Report company quality data including complaints, nonconforming product, and corrective/preventive action activities</li>
<li>Review non-conformities (NCRs) for determining root cause, creating corrective actions, providing customer follow up and close NCRs within an acceptable timeframe</li>
<li>Perform problem-solving tests to develop corrective actions for quality issues and to initiate continuous improvement</li>
<li>Report Quality metrics and trends routinely to the company </li>
<li>Conduct routine quality checks of product on the productions floor and report errors and process improvement recommendations</li>
<li>Coordinate returns to vendors and ensure corrective actions are in place to prevent future defects</li>
<li>Performs other duties as assigned. </li>
</ul>
Education:
<ul>
<li>Bachelor’s degree from an accredited higher learning institution, preferably in a Quality or Engineering related field.</li>
</ul>
 
Experience: 
<ul>
<li>Experience in high volume manufacturing environment, preferably in medical devices or in-vitro diagnostics</li>
<li>Experience with European IVDD and IVDR compliance and regulations </li>
<li>Experience with FDA 21 CFR Part 820 regulations</li>
<li>Minimum of 10 years’ experience related to quality assurance, lean manufacturing, regulatory compliance, and/or Six Sigma manufacturing</li>
</ul>
Qualifications: 
<ul>
<li>Holds Quality certifications in one or more of the following: ASQ/CQE, CMQ/OE, Six Sigma (Green or Black Belt)</li>
<li>Hands-on approach to troubleshoot and resolve quality related issues</li>
<li>Detail and Quality focused with strong organization, persuasion and negotiation skills</li>
<li>Ability to present information and respond to questions from various levels within the organization</li>
<li>Proficient in the use of MS Office</li>
<li>Thrives in a fast-paced, collaborative environment, efficiently works under pressures, within deadlines or other time essential constraints.</li>
<li>Excellent communication skills, both written and verbal, to clearly and concisely communicate to all levels of the organization.</li>
<li>Strong work ethic and an ability to excel within a rapidly changing and growing organization.</li>
</ul>
 
Compensation &amp; Benefits:
<ul>
<li>Salary Range: $130k-$140k, depending on location, experience, and qualifications.</li>
<li>Annual-Incentive Plan (AIP): Sr. Manager-level 15%</li>
<li>Benefits coverage begins day 1, including the following:
<ol>
<li>Medical, Dental, Vision Insurance</li>
<li>Disability Insurance </li>
<li>Life Insurance</li>
<li>401(k) company match</li>
<li>Paid Time Off (15 days annually)</li>
<li>Paid Holiday time (10 company-designated days)</li>
<li>Tuition Assistance </li>
<li>Additional benefits available with company package </li>
</ol>
</li>
</ul>
This position has not been approved for Relocation Assistance.
The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not an exhaustive list of all of the duties and responsibilities associated with it.
 
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.

Sr. Manager, Quality and Regulatory

<h3>Job Description</h3>
Job Description
Position Summary
The Director of Quality Operations is a critical leadership position responsible for ensuring the highest standards of quality and compliance in the sterile drug manufacturing process. This individual will lead and oversee key quality operations functions, while ensuring alignment with customer &amp; regulatory requirements and company objectives. The role requires a blend of technical expertise, analytical thinking, and leadership skills to address challenges, optimize processes, foster a culture of continuous improvement across the organization and enhance client relationships.
Duties and Responsibilities
<ul>
<li>Ensure compliance with cGMP, FDA, and other applicable regulatory requirements for sterile drug manufacturing.</li>
<li>Lead the team in quality oversight of manufacturing processes, ensuring adherence to SOPs and quality standards.</li>
<li>Drive initiatives to strengthen aseptic technique, contamination control strategies, and data integrity practices.</li>
<li>Support the development and maintenance of a robust risk management program, ensuring all critical issues are addressed with sustainable solutions.</li>
<li>Serve as the quality operations representative during internal and external meetings with clients and other entities.</li>
<li>Respond to client inquiries, quality concerns, and requests in a timely and professional manner.</li>
<li>Oversee the resolution of client-related deviations, investigations, and CAPAs, ensuring timely closure.</li>
<li>Provide root cause analysis and implement preventive measures for recurring client concerns.</li>
<li>Lead cross-functional teams to ensure effective resolution of quality issues impacting clients.</li>
<li>Facilitate effective communication between clients and internal stakeholders to ensure alignment on quality objectives.</li>
<li>Travel as needed</li>
<li>Other duties as assigned</li>
</ul>
Regulatory Responsibilities 
<ul>
<li>Keep abreast of changes to quality regulations and guidelines, advise the management team of any business implications of these changes</li>
<li>Maintain a detailed and comprehensive understanding of FDA, EU and other regulatory agency requirements</li>
<li>Conduct all work in compliance with FDA, 21 CFR 820, 21 CFR 210 and 211 and other regulatory agency requirements</li>
</ul>
Supervisory Responsibilities
<ul>
<li>Lead and direct work and provide feedback to a team of QA Specialists </li>
<li>Lead, manage and ensure proper training to any relevant change management programs throughout the company</li>
</ul>
Experience
<ul>
<li>Eight to ten (8-10) years of progressively responsible related quality assurance experience</li>
</ul>
Education
<ul>
<li>Bachelor's Degree</li>
</ul>
Knowledge, Skills &amp; Abilities
<ul>
<li>Subject matter expertise in FDA, EU, and other regulatory agency requirements</li>
<li>Comprehensive knowledge of QA concepts and principles</li>
<li>Knowledge of cGMP principles</li>
<li>Knowledge of RCA tools</li>
<li>Ability to work as part of a team</li>
<li>Management skills</li>
<li>Ability to manage multiple client relationships and priorities effectively</li>
<li>Good oral and written communication</li>
<li>Problem/situation analysis</li>
<li>Ability to build collaborative relationships</li>
<li>Uses good judgement</li>
<li>Perform complex work instructions and problem solving following established processes</li>
<li>Experience with Microsoft Office and general computer proficiency</li>
<li>Quality mindset and a willingness to develop yourself and others</li>
</ul>
Physical Requirements

<ul>
<li>Ability to remain stationary for long periods of time</li>
<li>Ability to move between locations</li>
<li>May occasionally lift up to 10 lbs.</li>
</ul>

Director of Quality Operations

<h3>Job Description</h3>
Job Description
 
Position Summary:Energetiq is seeking a Quality Engineering Manager to join a dynamic and growing technology company. This position will play an integral role in monitoring and improving the quality of Energetiq’s products and production operations. This is a hands-on management role responsible for guiding the quality team to resolve issues in manufacturing as well as ensuring all products meet our high-quality standards. This role requires a detail-oriented, technical mind, with a passion for quality and problem solving. This position reports to the Director of Quality and Manufacturing Engineering.Key Responsibilities:
<ul>
<li>Guide Energetiq’s Quality Engineering team, providing direction and support on failure investigation, root cause identification, FAI, incoming inspection, and continuous improvement activities.</li>
<li>Interface with customers to understand their quality needs, then propose and drive the team to execute projects to address those needs.</li>
<li>Create, analyze, present, and address KPIs for CAPAs, SCARs, NCMRs, warranty failures, and escapes.</li>
<li>Investigate and identify failure root cause and work with local and global Manufacturing and Product Engineering teams to drive a response.</li>
<li>Collaborate with the R&amp;D team to ensure new product designs meet customer requirements and Energetiq’s quality standards.</li>
<li>Interface with suppliers to ensure continued quality or provide guidance when quality standards are not met.</li>
<li>Manage outside consultants and sub-contractors where technical expertise does not exist in-house.</li>
<li>Lead and facilitate Quality Improvement and Kaizen events</li>
</ul>
Minimum Requirements and Qualifications:
<ul>
<li>Bachelor of Science in Mechanical, Electrical, Quality, Industrial engineering, or other relevant discipline.</li>
<li>8+ years of experience, with at least 3 years of experience in engineering management.</li>
<li>Ability and desire to actively engage with project work where required to meet goals.</li>
<li>Ability to lead, direct, develop, and discipline a team to achieve required goals.</li>
<li>Working knowledge of mechanical and electrical engineering to interact with subject matter experts on a complex electro-mechanical product.</li>
<li>Experience with failure investigation, CAPA, 8D, and reliability studies.</li>
<li>Advanced data analysis skills to identify trends in production or product quality issues.</li>
<li>Strong interpersonal skills to interact with internal and external stakeholders to provide and receive constructive criticism about product quality issues.</li>
<li>Approximately 20% global travel.</li>
<li>Valid passport and driver’s license.</li>
<li>Must occasionally lift or move up to 50 pounds, bend, squat, and/or work under and behind furniture and other obstacles. Occasional work in “clean room” environments, while wearing PPE, may be required.</li>
</ul>
Preferred Qualifications:
<ul>
<li>Master of Science in Mechanical, Electrical, Quality, Industrial engineering, or other relevant discipline.</li>
<li>Experience in the Semiconductor industry.</li>
<li>Experience with any/all: diode lasers, optics, opto-mechanical systems, optical metrology, Peltier modules, heat transfer, imaging systems, power electronics.</li>
<li>Advanced understanding of the design and/or root cause identification of electro-mechanical systems.</li>
<li>Experience with programming languages for data collection and analysis.</li>
</ul>

Quality Engineering Manager

<h3>Job Description</h3>
Job Description
About Us
We're more than just quality treatment for substance use disorders. We're a total health community. At SSTAR, our mission is healing the community, one person at a time. We will provide a personal level of healthcare and addiction treatment that addresses the mental, physical, and spiritual well-being of everyone we touch. SSTAR is a Federally Qualified Health Center (FQHC) which affords our employees eligibility to apply for one of our three Loan Repayment Programs, including the HRSA LRP. 
The Director of Quality, Compliance, and Risk requires a high degree of autonomy. This role provides oversight of all Compliance, Quality Assurance, and Risk Management initiatives. The Director investigates causes, diversions, and variations from practices. This role is responsible for the process of quality improvement efforts focusing on clinical quality, reviewing performance measures, and addressing patient complaints. In this role the Director serves as the champion of constant improvement.
Benefits
<ul>
<li>403B</li>
<li>Dental insurance</li>
<li>Disability insurance through Massachusetts PFML</li>
<li>Employee discounts, cell phone, eyewear etc.</li>
<li>Health insurance</li>
<li>Life insurance</li>
<li>Paid time off</li>
<li>Vision insurance</li>
<li>Flexible Spending Account</li>
<li>Opportunities to earn CEU's</li>
<li>Voluntary Benefits including but not limited to, Disability, Life, Critical Illness, Accident and Disability Insurances</li>
<li>Paid Long Term Disability</li>
</ul>
Duties &amp; Responsibilities
<ul>
<li>The Director of Quality, Compliance, and Risk promotes an environment in which the healthcare team can work cooperatively toward achieving departmental and facility goals and objectives.</li>
<li>Responsible for identifying and supporting best practices throughout the organization.</li>
<li>The Director of Quality, Compliance, and Risk manages risk by assuring agency follows, and factually interpretates all federal, state, and local laws, rules, and regulations including CMS Conditions of Participation, BSAS, Joint Commission, and HRSA.</li>
<li>Director prepares the agency for survey readiness by conducting survey activities and functioning as a Survey Coordinator along with other team members during surveys.</li>
<li>Assist with the development and monitoring of corrective action plans for regulatory statements and PI improvements.</li>
<li>The Director of Quality, Compliance, and Risk maintains quality and outcome data and uses the data to identify opportunities for improvement.</li>
<li>Reviews all event reports and notifies management of any incidents of high-risk significance followed by an intensive investigation and preparation of a root cause analysis.</li>
<li>The Director of Quality, Compliance, and Risk assists the CIO in the management of EHR and other data collection platforms as it applies to user compliance and quality outcomes.</li>
<li>Responsible for the maintenance, development and monitoring of all facility-wide policies and procedures.</li>
<li>The Director of Quality, Compliance, and Risk monitors and reports on the effectiveness of services through Performance Improvement, KPI's and other data collection methods.</li>
<li>Promotes a planned and systematic approach to Quality with the least amount of duplication and in the most cost-efficient manner.</li>
<li>Educates and trains Administration, Medical Staff, and employees on a full scope of PI Initiatives and their roles in performance improvement.</li>
<li>Oversees and works collaboratively with directors on all data collection and reporting processes.</li>
<li>Collects data, reviews, and reports all adverse incidents.</li>
<li>Coordinates principals to gather information related to patient complaints to ensure they are resolved and prepares written responses to patients. Trends complaints and provides meaningful insight for process or procedural improvements.</li>
<li>Coordinate and facilitate all SSTAR licensing and accreditation reviews.</li>
<li>Reviews/advises on proposed legislative and regulatory changes. Drafts comments/responses as requested.</li>
<li>Serves in the leadership for responding to Patient Grievances and the development of P&amp;P.</li>
<li>Responsible for providing meaningful feedback to departments, committees, and Medical Staff on a regular basis and timely manner. Demonstrates tact and discretion in this communication.</li>
<li>Will assume leadership/administrative responsibility for the coordination of or participating in the preparation of grant proposals.</li>
<li>Assists directors in the writing and updating of all policies and procedures.</li>
<li>Functions as a liaison, ensuring cooperation and effective interdepartmental relations as it relates to QA/PI.</li>
<li>Participates with Senior Leadership in the planning and development of programs as requested.</li>
<li>Chairs both the Risk Management and Compliance Committees and serves on the Performance Improvement Committee. Prepares quarterly and annual Board Reports.</li>
<li>Develop and maintain effective working relationships with outside agencies and departments.</li>
<li>Assists CEO and Directors with oversight supervision of contracted services.</li>
<li>Attends networking and educational opportunities for personal and organizational development.</li>
<li>Assists the CEO with non-payer facility contracting issues including securing Business Associate Agreements.</li>
</ul>
 
Education &amp; Experience
<ul>
<li>Bachelor's degree in Business/Healthcare Administration, Statistical Analysis, Quality Management, or related field required. Masters preferred.</li>
<li>Healthcare Compliance Certification, preferred.</li>
<li>Minimum of 5 years' experience in quality/process improvement with a minimum of 4 years in the healthcare or SUD treatment field. Previous quality assurance, compliance, and performance improvement experience required as well as experience working with regulatory/licensing authorities. HRSA experience preferred.</li>
<li>Strong analytical and computer skills.</li>
<li>Must be able to meet deadlines and manage multiple tasks adapting to shifts in priorities.</li>
<li>Strong written and verbal skills.</li>
</ul>

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