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