Sr QA Specialist
Wilmington, 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:
- Wilmington, MA: Relocate before starting work (Required)
Work Location: In person