Sr. Quality Assurance Manager - Manufacturing/Med Device

Piper Companies; Chelmsford (MA); On-site; USD 160,000 - 170,000; Full time

Job summary

Piper Companies is seeking a Senior Quality Assurance Manager for a medical device firm in Chelmsford, MA. The role involves overseeing QA operations, ensuring compliance with industry regulations, and driving a culture of quality within the organization. Candidates should possess strong leadership experience and a background in quality assurance within the medical device sector.

Benefits

Comprehensive benefits including Health, Vision, Dental

PTO and Paid Holiday

Sick Leave as required by law

Qualifications

• Minimum of 7 years of leadership experience in the medical device industry.
• Minimum of 12 years in quality/regulatory roles.
• Experience in a multinational matrix environment.

Responsibilities

• Develop and execute a Quality Assurance strategic plan.
• Maintain compliance with regulatory standards.
• Ensure audit readiness for inspections.

Skills

Quality management system

Audit readiness

Continuous improvement

Education

Bachelor’s degree in engineering, medical, or science disciplines

Advanced degree preferred

Tools

FDA 21 CFR Part 820

ISO 13485

MDSAP

Job description

Sr. Quality Assurance Manager - Manufacturing/Med Device

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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.
  
  

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

#ONSITE

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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