Sr. QA Manager
Listed on 2026-02-06
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Quality Assurance - QA/QC
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Healthcare
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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. The Senior Quality Assurance Manager is pivotal in ensuring compliance with regulatory standards and driving continuous improvement initiatives.
Responsibilities of the Senior Quality Assurance Manager include:
- 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.
- $160, + 16% annual bonus/RSUs.
- Comprehensive benefits package.
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Seniority level
- Seniority level
Mid-Senior level
- Employment type
Full-time
- Job function
Quality Assurance - Industries Business Consulting and Services
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