Senior Quality Assurance Manager
Job in
Boston, Suffolk County, Massachusetts, 02298, USA
Listed on 2026-10-18
Listing for:
Piper Companies
Full Time
position Listed on 2026-10-18
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Job Description & How to Apply Below
Piper Companies is seeking a Senior Quality Assurance Manager to lead quality assurance efforts for a medical device facility in Chelmsford, MA through a M-F Onsite work schedule.
Responsibilities- Lead quality assurance for two products: balloon pump and balloon catheter.
- Develop and execute QA strategies to ensure compliance and excellence.
- Foster a culture of quality across the organization.
- Ensure the Quality Management System (QMS) complies with global standards, including FDA 21 CFR Part 820 and ISO 13485.
- Minimum of 5+ years of management experience in the medical device industry and 10+ years overall experience.
- Strong experience with FDA audits, including some experience in leading audits.
- Extensive experience with compliance of medical devices, specifically 21 CFR Part 820 and ISO 13485.
- Bachelor's Degree required.
- Experience with catheters is a bonus.
- Must work onsite 5 days a week in Chelmsford, MA.
- Must be eligible to work in the United States.
Compensation for the Senior Quality Assurance Manager includes: $160, + 16% annual bonus/RSUs.
Comprehensive benefits package.
Position Requirements
10+ Years
work experience
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