Sr. Quality Assurance Manager - Manufacturing/Med Device

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

Job summary

A leading company is seeking a Sr. Quality Assurance Manager for their Chelmsford, MA location. This role involves overseeing QA operations, driving continuous improvement, and ensuring compliance with regulatory standards. The ideal candidate will have extensive experience in quality assurance within the medical device industry and will work onsite five days a week. Comprehensive benefits and a competitive salary package are offered.

Benefits

Health Insurance

Vision Insurance

Dental Insurance

PTO

Paid Holidays

Sick Leave

Qualifications

• At least 7 years of leadership experience in the medical device industry.
• Total of 12+ years in quality/regulatory roles.

Responsibilities

• Develop and implement a QA strategic plan aligned with business goals.
• Ensure compliance with global quality and regulatory standards.
• Maintain audit readiness for inspections.

Skills

Leadership

Quality Management

Regulatory Compliance

Continuous Improvement

Education

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

Advanced degree preferred

Job description

Sr. Quality Assurance Manager - Manufacturing/Med Device

Join to apply for the Sr. Quality Assurance Manager - Manufacturing/Med Device role at Piper Companies.

Position Overview: Piper Companies is hiring a Senior Manager of Quality Assurance (Manufacturing/Medical Device) for a medical device company in Chelmsford, MA. The role involves overseeing QA operations, driving continuous improvement initiatives, and fostering a culture of quality across the organization. The Senior Manager will be required to work onsite 5 days a week in Chelmsford, MA.

Responsibilities:

• Develop and implement a Quality Assurance (QA) strategic plan aligned with business goals to enhance engagement and accountability.
• Ensure compliance with global quality and regulatory standards such as FDA 21 CFR Part 820, ISO 13485, MDSAP, among others.
• Improve governance and management practices, focusing on continuous improvement and achieving objectives.
• Represent QA on the site leadership team, aligning regional and global quality goals.
• Maintain audit readiness for internal, third-party, and regulatory inspections.
• Adhere to the organization’s Code of Conduct, policies, and industry standards.

Requirements:

• Bachelor’s degree in engineering, medical, or science disciplines (advanced degree preferred).
• At least 7 years of leadership experience in the medical device industry, with a total of 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.
• Audit experience with regulatory bodies is desirable but not mandatory.

Compensation:

• $160,000-$170,000 base salary plus bonus and equity.
• Comprehensive benefits including health, vision, dental, PTO, paid holidays, and sick leave as required by law.

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