Sr. Quality Assurance Manager - Manufacturing/Med Device
Join to apply for the Sr. Quality Assurance Manager - Manufacturing/Med Device role at Piper Companies
Sr. Quality Assurance Manager - Manufacturing/Med Device
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Join to apply for the Sr. Quality Assurance Manager - Manufacturing/Med Device role at Piper Companies
Piper Companies is hiring a Senior Manager of Quality Assurance (Manufacturing/Medical Device) for a medical device company located in Chelmsford, MA. The Senior Manager of Quality Assurance (Manufacturing/Medical Device) will oversee QA Operations, derive continuous improvement initiatives and foster a culture of quality across the organization. The Senior Manager of Quality Assurance (Manufacturing/Medical Device) will need to work onsite 5 days per week in Chelmsford, MA.
Responsibilities for the Senior Manager of Quality Assurance (Manufacturing/Medical Device):
- Develop and execute a Quality Assurance (QA) strategic plan, aligning team objectives with business goals to drive engagement and accountability.
- Maintain compliance with global quality and regulatory standards, including FDA 21 CFR Part 820, ISO 13485, MDSAP, and other applicable regulations.
- Enhance governance and management practices, ensuring continuous improvement and goal delivery.
- Represent QA on the site leadership team, ensuring alignment between regional and global quality objectives.
- Ensure audit readiness for internal, third-party, and regulatory inspections.
- Maintain compliance with the organizations Code of Conduct, corporate policies, and industry standards.
- Bachelors degree in engineering, medical, or science disciplines (Advanced degree preferred).
- Minimum of 7 years of leadership experience in the medical device industry, with 12+ years in quality/regulatory roles.
- Expertise in US Quality System Regulation (21 CFR Part 820), ISO 13485, and Medical Device Regulation.
- Experience working in a multinational matrix environment with strong business acumen and influence.
- Audit experience with regulatory bodies (desirable but not required).
- $160,000-$170,000 base + bonus + equity
- Comprehensive Benefits: Health, Vision, Dental, PTO, Paid Holiday, Sick Leave if required by law
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This job opens for applications on 5/30/2025. Applications for this job will be accepted for at least 30 days from the posting date.
Seniority level
Seniority level
Director
Employment type
Employment type
Full-time
Job function
Job function
Quality Assurance-
Industries
Business Consulting and Services
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