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<h3>Job Description</h3>
WHO WE ARE
Nextphase.ai is a Data Management solution provider focused on Data Operations services for enterprise data in the cloud. We are leading the innovation agenda with our clients by delivering a portfolio of services to help them improve data quality and manage data governance for their cloud data. NextPhase.ai data management services are tailored to achieve our client’s business outcomes thus enabling our clients to focus on monetizing their data while we handle data operations. Nextphase.ai provides you with a dynamic and fun work environment and encourages you to use creative thinking to solve client challenges.
 
Position Overview:
We are seeking a dynamic, analytical thinking individual to join our Quality team, this is a contract position focusing on Quality Systems, CAPA, Complaint handling, Internal Audit, metric reporting and process improvement initiatives. The ideal candidate will possess a strong background in medical devices or IVD, with a proven track record in managing quality-related activities in a fast-paced dynamic environment. QMS experience is essential.
 
Responsibilities:
This position is responsible for, but not limited to, the following:
<ul>
<li>Supports the overall QMS processes for the organization. Responsible for activities required to ensure compliance of Quality Management Systems (QMS), specifically regarding CAPA, complaints and internal/external audits. Additional responsibilities include supporting other QMS functions such as NCMRs, Supplier Controls, Management Review, Risk Review, etc.</li>
<li>Execution and coordination of activities associated with CAPA program, including administration and record management, providing quality input to investigations, reporting, as well as metrics and trending</li>
<li>Support CAPA Owners in quality-related technical principles, including but not limited to Problem Solving tools and techniques (Root Cause Analysis, DOE, FMEA, etc.)</li>
<li>Investigate customer complaints, from intake through investigation and closure</li>
<li>Manages the Internal Audit program, including scheduling audits, ensuring timely response to findings, as well as metrics and trending</li>
<li>Development of Quality Metrics, and coordination of quality data collection and analyses for use in monthly metrics meetings and Management Reviews</li>
<li>Provide quality assurance support cross-functionally across the organization</li>
<li>Develop, implement, and manage Quality Control/Quality System process improvements.</li>
<li>Identify opportunities for improvement within the Quality System to ensure compliance and efficiency. Correct or improve gaps/opportunities in an independent fashion by writing and releasing new or revised Quality System documentation</li>
<li>Understand how and when to escalate quality issues to leadership team within the organization, presenting data and information necessary to draw conclusions and take action</li>
<li>Provide training and support to employees on quality processes and procedures</li>
<li>Support work on quality plans, quality processes</li>
</ul>
 
Minimum Qualifications:
<ul>
<li>Bachelor’s Degree in Engineering, Biomedical Science, or other technical discipline preferred, with 3-6 years of relevant experience in medical device industry, including responsibility for Product Quality and/or Quality Systems</li>
<li>A working knowledge of Quality System Standards and regulations, including 21 CFR Part 820, ISO 13485, EU MDR</li>
</ul>
 
Preferred Qualifications:
<ul>
<li>Ability to multitask, handling multiple projects and changing priorities</li>
<li>Experience in the creation and documentation of procedures and processes</li>
<li>Must be results-driven and exhibit a sense of urgency</li>
<li>Proficiency with Microsoft Office - Word, Excel, PowerPoint and Access experience required</li>
<li>Ability to communicate ideas and information clearly, effectively, and frequently (both oral and written)</li>
<li>Ability to exercise independent judgment in methods, techniques, and evaluation criteria for obtaining results</li>
<li>Ability to act independently to determine methods and procedures</li>
<li>Problem-solving skills and the ability to resolve issues as they arise</li>
<li>Strong interpersonal skills, with the ability to assimilate with various cross-functional teams</li>
</ul>
 
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship or employment visas currently.
 
NextPhase.ai is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Quality Systems Engineer (Medical Devices Industry) @ Andover, MA

<h3>Job Description</h3>
Role: NPD Quality Engineer
Location: Plymouth, MN (Onsite)
Job Type: Full Time
 
Job Description
Must Have Technical/Functional Skills
• Knowledge on Quality Management and its tools &amp; techniques
• Knowledge about GMP (Good Manufacturing Practices), FDA, ISO 13485 and compliance regulations
• Knowledge on Medical Device Regulatory Standards, MDD and MDR
• Knowledge on NC, CAPA, Root Cause Analysis and Audit processes
• Knowledge on Validation process, writing protocols/ reports
• Very good understanding/ experience in writing procedures, product specs and work instructions
• Knowledge in Statistics, Risk Management and Design control
• Must possess good communication skills (verbal and written), familiar with project management methodology, problem solving, and presentation skills
• Experience in creating FMEAs &amp; Writing reports
• Experience in PMS (Post Market Surveillance)
• Experience in PLM Tool (Windchill)
• Good understanding of Design, Drawing and GD&amp;T
• Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred
• Personal computer skills, Windows: word processing, presentation, e-mail, web browsers &amp; spreadsheet software
• Ability to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc.)
Roles &amp; Responsibilities
• Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson &amp; Johnson, procedures and guidelines, the duties and responsibilities for this position are:
• Development and review of PDP (Product development Process) deliverables
• Review and approve R&amp;D/ Engineering protocol/ reports
• Development of Risk management records (i.e. DFMEA/ PFMEA) in collaboration with SMEs
• Support and provide guidance on Validations and if required write Validation Protocols/ Reports
• Support/ Remediation of Validation/ Quality Documentation
• Support Root Cause Investigation and closure of NC and CAPA
• Review and approve the Change Orders (CR/ CN)
• Review and update the design/ process control documents like procedures/ work instructions/ product specs etc.
• Work with cross functional teams and internal teams to create deliverables
• Performs other duties assigned as needed
 
Salary Range: $90,000 $95,000 Year
 
TCS Employee Benefits Summary:
Discretionary Annual Incentive.
Comprehensive Medical Coverage: Medical &amp; Health, Dental &amp; Vision, Disability Planning &amp; Insurance, Pet Insurance Plans.
Family Support: Maternal &amp; Parental Leaves.
Insurance Options: Auto &amp; Home Insurance, Identity Theft Protection.
Convenience &amp; Professional Growth: Commuter Benefits &amp; Certification &amp; amp; Training Reimbursement.
Time Off: Vacation, Time Off, Sick Leave &amp; Holidays.
Legal &amp; Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.

NPD Quality Engineer

<h3>Job Description</h3>
Production Support Specialist (Afternoons: 1:30PM – 9:30PM)
Salary Range:$31.50 - $35.00 per hour 
 
The Production Support Specialist role is responsible for leading Material Review Board (MRB) reviews, approving dispositions through review of Design/CAD Model, coordinating, and maintaining documentation, and working cross functionally to investigate causes, containment actions and final solutions for issues detected during our manufacturing and assembly process.
 
Key Responsibilities
 
<ul>
<li>Lead Manufacturing Review Board reviews with core team members to determine non-conformance resolutions.</li>
<li>Create action notices to communicate to appropriate departments and personnel all revision and Bill of Material updates, as well as actions used to process changes from Design</li>
<li>Communicate directly with suppliers and utilize the Engineering Deviation Request (EDR) process to review and obtain approval for requests.</li>
<li>Facilitate the implementation of determined actions from Non-conformance, Engineering Change Orders, and EDR reviews.</li>
<li>Collaborate with Manufacturing team leaders and in cross function teams to perform root cause analysis and ensure corrective action implementation (CAR) to reduce risk and support continuous improvement initiatives.</li>
<li>Review design model and design repairs in CAD model to ensure effective solutions without compromising quality.</li>
<li>Proactively work to provide containment of quality concerns both internally and externally for our customers.</li>
<li>Manage and perform thorough follow up on issue status’ and resolution progress </li>
<li>Record and document disposition of non-conformities in the ERP quality system </li>
<li>Oversee the product on-hold / off-hold process and communicate with other departments as necessary</li>
<li>Support and/or Lead Quality team projects for continuous improvement initiatives as needed.</li>
</ul>
 
Qualifications
 
<ul>
<li>Technical education and hot runner design experience preferred</li>
<li>Must demonstrate an Intermediate to advanced understanding of drawings and the utilization of 3D solid CAD models</li>
<li>In depth knowledge of Husky Hot Runner Systems </li>
<li>Solid understanding of our manufacturing and sourcing processes </li>
<li>Solid MS Office skills (Excel, PowerPoint, Word &amp; Outlook) </li>
<li>Ability to multi-task and manage multiple communications through use of time management skills to prioritize, organize, and provide timely responses.</li>
<li>Must demonstrate strong problem resolution and decision-making skills, with an ability to work closely with others to coordinate completion of tasks</li>
<li>Excellent troubleshooting skills, ownership, and customer focus </li>
<li>Flexibility to work overtime as needed and/or to be on call as required</li>
<li>Excellent communication skills</li>
</ul>

Production Support Specialist

<h3>Job Description</h3>
Our client is looking for a production manager, and they are synonymous with excellence in quality, dependability and customer service. They are an international tier-one supplier of high-speed chain drive systems to the automotive industry.
 
The Production Manager will be responsible for overseeing the Chicopee location's production processes to ensure all safety, quality, delivery, and cost (efficiency and continuous improvement) objectives are achieved for production. Responsible for consistently finding ways to improve organizational production processes and through building and leading a team to meet the organizational objectives.
 
Essential Duties and Responsibilities:
<ul>
<li>The essential duties and responsibilities of this job are included but not limited to this job description – other tasks may be assigned and expected to be performed.</li>
<li>Manages all resources in a harmonious manner that promotes and cultivates an atmosphere that emphasizes teamwork, respect, accountability, and a desire to improve all Safety, Quality, Delivery and Cost objectives</li>
<li>Ensures all EHS standards, process and procedures are followed, work directly with EHS Site Lead as needed to improve existing program/procedures to ensure all EHS objectives are regularly exceeded.</li>
<li>Ensures all Quality standards, process and procedures are followed, works directly with Quality and Engineering Departments as needed to improve existing program/procedures to ensure all Quality objectives are regularly exceeded.</li>
<li>Ability to align production goals with broader organizational objectives.</li>
<li>Demonstrates the ability to respond to changing priorities and unexpected issues, by guiding the team through transitions with clarity and confidence.</li>
<li>Plan and establish production and manufacturing priorities</li>
<li>Utilizing systems to monitor all production related data regarding department loads, capacities, quantities, and delivery dates of all customer demand.</li>
<li>Advises and monitors production schedules and priorities as result of equipment failure or operating problems.</li>
<li>Ensures on-time delivery to all internal and external customers.</li>
<li>Communicates monthly production requirements and Coordinates production activities with supporting departments, engineering, procurement, maintenance, and quality control activities to obtain optimum production and utilization of resources, machines and equipment.</li>
<li>Develop and implement strategies designed to correct operational problems and improve production throughput.</li>
<li>Develop long range production plan and capital improvements.</li>
<li>Recruits, interviews, hires, and trains new staff in the department. Provides constructive and timely performance evaluations.</li>
<li>Oversee the daily workflow of the department and collaborates with other manufacturing managers and leadership to set and assess priorities across teams.</li>
<li>Has the responsibility of establishing daily/weekly/monthly schedules and is responsible for ensuring timelines are achieved and communicated accordingly.</li>
<li>Monitors manpower and training plans to maintain area targets.</li>
<li>Establishes environment of Continuous Improvement to eliminate problems and reduce costs. Training, teamwork, and communication are keys.</li>
<li>Ensures compliance and consistency with all factory rules, regulations, and collective bargaining agreement. Supports system of progressive discipline and develops consistency among supervisory ranks. Works to develop a progressive approach to union related issues.</li>
<li>Proactively identifies opportunities for process improvement and cost savings.</li>
<li>Develops, fosters and leads/mentor’s teams to achieve significant results and develop future leaders/managers.</li>
<li>Fully understands personal accountability and responsibility and holds own self to that standard.</li>
<li>It is the expectation of the company that Managers/Supervisors will accomplish these goals by working to a high ethical standard and consistently complying with all company policies, work rules, Union Contractual agreements, and applicable laws with little to no direct supervision.</li>
</ul>
 
Requirements:
<ul>
<li>Bachelor’s degree required. Master's degree preferred.</li>
<li>10+ years of progressive experience in production or manufacturing management, preferability in a high volume, fast paced environment.</li>
<li>Proven track record of leading cross functional teams to meet production targets, improve efficiency and maintain quality standards.</li>
<li>Experience in developing and implementing production schedules, managing workflow and optimizing resource allocation.</li>
<li>Demonstrates ability to analyze production metrics and drive continuous improvement initiatives using Lean, Six Sigma or other methods.</li>
<li>Familiarity with compliance standards including OSHA and Quality Management systems (IATF, ISO).</li>
<li>Automotive Tier 1 experiences highly desired.</li>
<li>History of mentoring and developing team members, fostering a culture of safety, accountability and performance.</li>
<li>Experience working in a union plant required.</li>
</ul>

Production Manager

<h3>Job Description</h3>
Job role: CMM Programmer Location: Lynn,MA Duration: Contract Responsibilities: The Process Engineer will be responsible for programming Coordinate Measuring Machines (CMM) to support the manufacturing efforts. The CMM programming will be done using PC DMIS. The role will include writing, editing, troubleshooting, and validating CMM programs to be used for measurement of jet engine components. The Process Engineer develops, enhances, and troubleshoots CMM programs for dimensional inspection of manufactured aerospace products. The Process Engineer must be able to read and interpret drawings and prints using Geometric Dimensioning and Tolerancing (GD&amp;T) principals. Duties and Responsibilities: Develop CMM programs using PC DMIS, an advanced level of PC DMIS offline programming is expected. Read and understand prints/drawings and have an advanced knowledge of GD&amp;T. Develop planning, processes, and work instructions Troubleshoot &amp; prove-out CMM/PC DMIS programs, direct GR&amp;R validations, and validate work using multiple techniques Develop CAD based CMM inspection programs using both models and prints Work autonomously as well as collaboratively in identifying needs and validation plans. Providing proactive support to meet manufacturing requirements Follow system standards to development, implementation, and change management of metrology processes Qualifications / Requirements: US citizenship required Approximately 20% travel time Advanced knowledge/experience programming CMM’s using PC DMIS with scanning, offline programming, and complex geometry. Advanced knowledge/experience programming CMM’s using PC DMIS software with an emphasis on precision, repeatability and reproducibility Strong experience using, programming, troubleshooting, and editing PC DMIS programs. Experience using 5-axis REVO probe systems. Strong knowledge of GD&amp;T and how to apply GD&amp;T to inspection routines to satisfy print dimensions Strong mathematical, analytical, writing, and communication skills Knowledge and experience with CAD-based inspection using PC DMIS Strong collaboration &amp; presentation skills in order to gain buy-in &amp; effectively communicate program/process implementations and changes to the organization Desired Characteristics: Programming or scripting experience (C++, C Sharp, Python, etc.) Self-starter – quick learner &amp; able to identify alternative solutions for optimum results Experience in application of structured problem solving in continuous improvement

Coordinate Measuring Machine Programmer

<h3>Job Description</h3>
Millennium Corporation is hiring an Integrated Master Scheduler at Hanscom Air Force Base, MA. Qualified candidate must have a Secret clearance.
 
<ul>
<li>Provide support to the Air Force Life Cycle Management Center (AFLCMC/HBD), Theater Battle Control Division.</li>
<li>Communicate and coordinate Integrated Master Schedule (IMS) activities among the functional disciplines within the PMO</li>
<li>Provide IMS technical products such as GANTT charts and network diagrams</li>
<li>Ensure integrated schedule management technical support to system acquisition processes</li>
<li>Collaborate and incorporate key schedule requirements to ensure mission success</li>
<li>Support requirements development and planning and assess the ability to achieve results</li>
<li>Communicate schedule objectives, plans, and status updates to the customer, the project team, and management teams</li>
<li>Perform corrective actions as necessary to achieve end results</li>
</ul>
 
Requirements:
<ul>
<li>Have an active Secret security clearance</li>
<li>10 years of experience (5 years must be supporting a military client)</li>
<li>Bachelor’s degree from an accredited college/university</li>
<li>Prior history communicating and coordinating Integrated Master Schedule activities</li>
<li>Successful ability to produce GANTT charts and network diagrams</li>
<li>Advanced understanding of Microsoft Project</li>
</ul>

Integrated Master Scheduler

<h3>Job Description</h3>
&amp;#x1F680; Contract Opportunity – Quality Engineer (Edifecs Project)
 
 &amp;#x1F4CD; Remote (U.S.-based only) | &amp;#x1F4BC; 7-Month Contract | &amp;#x1F4B0; W2 Only
 
We’re looking for experienced Quality Engineers to join a remote Edifecs project within the U.S. healthcare domain. This is a 7-month W2 contract opportunity with a leading healthcare technology team.
 
Key Responsibilities
<ul>
<li>Review business requirements and data mappings related to the HealthRules Payor ecosystem.</li>
<li>Perform manual testing, create and execute test cases, and document results.</li>
<li>Design or contribute to comprehensive testing plans.</li>
<li>Conduct SQL-based validation and data analysis.</li>
<li>Collaborate with technical and business teams to ensure data accuracy and functional integrity.</li>
<li>(Optional) Contribute to testing automation or agentic testing initiatives.</li>
</ul>
 
Required Skills &amp; Experience
<ul>
<li>Strong background in U.S. Healthcare systems and processes.</li>
<li>Hands-on experience with HealthRules Payor and HealthRules Data Warehouse.</li>
<li>Proficiency in SQL for validation and data testing.</li>
<li>Demonstrated experience creating and executing manual test cases.</li>
<li>Excellent attention to detail, documentation, and communication skills.</li>
<li>Must be authorized to work in the U.S. (W2 only) and reside within the United States.</li>
</ul>
 
Nice to Have
<ul>
<li>Familiarity with Edifecs integration and testing frameworks.</li>
<li>Exposure to automation or agentic testing tools.</li>
</ul>
 
&amp;#x1F4E9; Interested? Apply today to join a dynamic remote team working on a transformative U.S. healthcare project.

Quality Engineer (Edifecs Project)

<h3>Job Description</h3>
WHO WE ARE 
We are a leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Join a company where collaborative, dedicated, and talented people are the backbone of our culture. Work both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.
THE ROSLINCT WAY 
Here at RoslinCT, our team contributes to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people’s development, growth, and the ability to impact patients.
ACCELERATING YOUR FUTURE 
The Process Engineer I/II will develop and execute technology transfer plans for RoslinCT’s client processes, including working with key stakeholders in Manufacturing, Quality, Technology, and Operations departments. As a technical subject matter expert, the position will support routine production with troubleshooting, technical assessments of deviations, and product disposition evaluations. The position will play a key role in optimizing manufacturing processes and test methods, continuously improving quality, efficiency, and reliability while supporting products through clinical development to commercialization. 
HOW YOU WILL MAKE AN IMPACT 
<ul>
<li>Partner with colleagues in Operations, Quality Control, and Quality Assurance as well as external clients and suppliers to plan technology transfer, equipment setup and qualification, engineering and training runs, and process validation as applicable. </li>
<li>Support production and QC with process or equipment troubleshooting, deviation management, corrections and CAPA, as needed </li>
<li>Execute feasibility testing of new or alternative technologies and engage with key stakeholders to ensure technology development alignment with RoslinCT and Client program requirements </li>
<li>Collaborate with internal partners to experimentally determine key process and product monitoring and control attributes, analyze results and draft technical reports to communicate conclusions </li>
<li>Perform test runs and development studies as needed to support client and RoslinCT initiatives </li>
<li>Compile comprehensive data packages, operating procedures, and technical documentation to support technology transfer and process improvement </li>
<li>Be proactive in identifying opportunities to add value to processes and cross-functional teams </li>
</ul>
WHAT YOU WILL BRING
<ul>
<li>B.Sc. in Biological or Chemical Engineering (or similar) with 2-10 years of relevant process and/or analytical experience within the Cell and Gene Therapy or Biologics industry </li>
<li>Hands-on experience with aseptic manufacturing processes, cell culture, and process analytics </li>
<li>Experience with equipment support and troubleshooting </li>
<li>Demonstrated independence in experimental design, execution, data analysis, and troubleshooting </li>
</ul>
 Preferred Qualifications
<ul>
<li>Advanced degree or additional certifications in science, engineering, or cGMP operations </li>
<li>Experience with bioreactor cell culture</li>
<li>Experience with cell selection, cell washing, lentiviral transduction, and cryopreservation </li>
<li>Experience with Microsoft Excel and statistical programs for data analysis and visualization </li>
<li>Excellent technical writing and oral communication skills </li>
<li>Driven and works well independently and within cross-functional teams </li>
</ul>
*May serve in an “on call” rotation to respond remotely to urgent issues (~1 week per month) 
 
OUR COMMITMENT
All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.
RoslinCT is proud to be an equal opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.

Process Engineer

<h3>Job Description</h3>
W2 role. Onsite role
Locations: Merrimack, NH and Westlake, TX
 
Industry Expertise: Brokerage trading systems experience is required.
 
Job Title: Senior Automation Engineer
Location: Westlake, TX or Merrimack, NH
Duration: 12+ Months
This is a W2 role. No C2C allowed
 
Required Skills
<ul>
<li>8-9+ years of experience</li>
<li>SQL (being able to do multiple joins from 2-3 tables) and Java (read and de-bug code) will be important for this one -</li>
<li>Must be able to read and debug Java code</li>
<li>Testing &amp; Automation: Solid experience testing brokerage industry financial applications, with hands-on test automation using BDD frameworks (Cucumber/Selenium) and executing automation in CI/CD pipelines.</li>
<li>Data &amp; Reporting: Strong SQL for writing and executing complex queries and exposure to PowerBI (must be willing to learn) preferred</li>
<li>Industry Expertise: Brokerage trading systems experience is required.</li>
</ul>
 
*Interview Process*
1 round
Screen sharing coding for SQL and Java
 
The Expertise We’re Looking For
<ul>
<li>Solid experience testing brokerage industry financial applications</li>
<li>Test automation experience using BDD framework built using Cucumber/ Selenium</li>
<li>Running automation in a CI/CD pipeline.</li>
<li>Experience working in agile Software Development Lifecycle</li>
<li>Strong SQL experience - candidate must be able to write and execute complex queries.</li>
<li>Experience in middle tier coding using Java a plus.</li>
<li>Front end development using Angular, JavaScript a plus.</li>
<li>Backend development skills – Oracle SQL a plus</li>
</ul>
 
 
Regards,
 
Yogesh Singh Rana
Lead Recruiter
412-286-1371
<a href="mailto:Yogesh.Rana@Mastechdigital.com" target="_blank">Yogesh.Rana@Mastechdigital.com</a>

Automation Engineer

<h3>Job Description</h3>
Job Description
Machine (Saw) Operator is a full-time manufacturing plant position. Initially the new hire will be trained to operate several different types of foam cutting saws, with the ability to move into a other roles quickly after demonstrating ability to run machines. Carpentry/woodworking or similar experience would qualify a candidate for this Machine Saw operator position. MUST be able to read a tape measure and have math skills to multiply and divide. The Machine Operator position is in Fitchburg, MA.
Job Type: Full-time
Salary: $17.00 to $20.00 /hour

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