Senior Quality Assurance Specialist

Sr QA Specialist
Lexington, MA
$90,000 - $120,000 depending on experience
Medical Device

Position Overview:

Our client are seeking a dynamic, analytical thinking individual to lead their Quality Assurance team, focusing on complaint handling, post-market surveillance, and process improvement initiatives. The ideal candidate will possess a strong background in IVD or medical devices, with a proven track record in managing quality-related activities. QMS experience is essential.

Responsibilities:

• Spearhead the Complaint Handling Unit, overseeing meetings, tracking deliverables, and ensuring the prompt resolution of customer complaints.
• Contribute to post-market surveillance efforts by collecting and managing relevant information, maintaining databases, and assisting in documentation for regulatory reporting.
• Drive process improvement initiatives for enhanced field action readiness, involving internal documentation reviews and effective communication with regulatory authorities.
• Apply risk assessment principles according to ISO 14971 to make informed decisions related to our processes and products.
• Author, monitor, and ensure the effectiveness of actions taken to address quality observations, including complaints, corrective and preventative actions, changes, and other quality enhancements.
• Collaborate closely with Regulatory Affairs, Service, and Quality Assurance Compliance teams, completing assigned tasks within specified timelines.
• Provide valuable support for document management and training system administration.
• Actively contribute to the ongoing enhancement of our Quality Management System (QMS).
• Support audit preparation activities and actively participate in audit discussions.
• Effectively track project and quality plan deliverables.

Skills and Expertise:

• Hold a Bachelor's degree in Biology, Chemistry, Applied Biomedical Science, or an equivalent field.
• Possess a solid understanding of FDA QSR, ISO 13485, ISO 14971, and IVDR.
• Bring 5-7 years of Quality Assurance experience in the in-vitro diagnostic or medical device field.
• Demonstrate proficiency in handling customer complaints, medical device reporting, and post-market surveillance activities.
• Showcase expertise in Root Cause Analysis and structured problem-solving methodologies.
• Previous experience in quality auditing, both internal and external, is highly desirable.
• Thrive in a fast-paced work environment and possess excellent time-management, organizational, and communication skills.
• Work independently while collaborating seamlessly with multiple departments.
• Exhibit strong multitasking abilities and manage multiple projects simultaneously.

Job Type: Full-time

Salary: $90,000.00 - $120,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Retirement plan
• Tuition reimbursement
• Vision insurance

Experience level:

• 5 years

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person
• Manufacturing facility
• Office

Education:

• Bachelor's (Preferred)

Experience:

• Quality management systems: 5 years (Preferred)
• ISO 13485: 4 years (Preferred)
• Audit: 4 years (Preferred)
• Quality assurance: 4 years (Preferred)

Ability to Relocate:

• Lexington, MA: Relocate before starting work (Required)

Work Location: In person