Job Description
Job Description
Join Our Quality Team as a Quality Systems Senior Specialist!
Are you a seasoned Quality professional with a passion for ensuring excellence in medical imaging, diagnostics, or therapeutics? We are seeking a highly motivated Quality Systems Senior Specialist to join our team in Bedford, Massachusetts. This is an exciting opportunity to be part of an agile and growing organization focused on pioneering advancements in patient care.
In this critical role, you will oversee key aspects of our Quality System, contributing directly to our commitment to high standards and regulatory compliance. If you thrive in a dynamic environment and are dedicated to continuous improvement, we encourage you to apply!
This position is site-based with a requirement to be on-site 4 days per week.
INTERESTED? APPLY NOW!FOR MORE IMMEDIATE CONSIDERATION, email a current resume to iris.levy@randstadusa.com
salary: $50 - $57 per hour
shift: First
work hours: 8 AM - 5 PM
education: Bachelors
Responsibilities
- Perform internal audits and other inspection walkthroughs, as well as reviewing documents for compliance to regulatory guidelines and internal process requirements.
- Support external audits through back-room audit support.
- Create new and/or revise existing quality system documentation.
- Develop and support quality metrics initiatives.
- Initiate complaints within the Quality Management System (QMS)
- Perform Product Quality Complaint Investigations and drives closure of associated CAPA(s).
- Collaborate with Technical Support, Engineering, Analytical Laboratories, Manufacturing, Validation, Customer Service and Regulatory Affairs groups to ensure timely complaint investigations and closure.
- Perform routine trending of product complaints and evaluates trends, escalating issues as necessary.
- Evaluate scientific data for trends, drives Investigations, and proposes the need for changes to manufacturing or control procedures.
- Support writing and approval cycle for Annual Product Quality Reports (APQR). Manages the development of less complex APQRs, collaborating with internal stakeholders.
- Foster an environment that drives continual improvement, and champions a quality culture throughout the organization.
- Actively promotes safety rules and awareness. Demonstrate good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety and environmental hazards.
Skills
- Quality Control
- Quality Assurance
- Quality Auditing
- cGMP (2 years of experience is required)
- Product Quality Complaints (1 year of experience is required)
- Inspection
- Years of experience: 5 years
- Experience level: Experienced
Qualifications
Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.