Sr. Quality Assurance Manager - Manufacturing/Med Device

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.

Requirements for the Senior Manager of Quality Assurance (Manufacturing/Medical Device):

• Bachelor’s 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).

Compensation for the Senior Manager of Quality Assurance (Manufacturing/Medical Device):

• $160,000-$170,000 base + bonus + equity
• Comprehensive Benefits: Health, Vision, Dental, PTO, Paid Holiday, Sick Leave if required by law

Keywords: Senior Quality Assurance Manager, QA leadership, quality management system, FDA 21 CFR Part 820, ISO 13485, MDSAP compliance, medical device quality, regulatory compliance, continuous improvement, audit readiness, cross-functional collaboration, product testing, batch release, documentation review, process control, field actions, site QMS, governance practices, talent development, matrix environment, business acumen, operational excellence, risk management, culture of quality, medical device industry, strategic planning, mentorship, coaching, organizational capability, regulatory audits

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This job opens for applications on 5/9/2025. Applications for this job will be accepted for at least 30 days from the posting date.