Sr. Quality Assurance Manager

Direct Hire

Onsite - Chelmsford, MA

Base salary around $155-178K w/ a 16% bonus and eligible for long-term incentive plan

This will be the highest-level quality person at the site

**Need someone who comes from the operations manufacturing side along with medical device experience (electro-mechanical medical devices)**

PRINCIPAL RESPONSIBILITIES:

Team Leadership

• Develops and leads the execution of the Quality Assurance (QA) strategic plan, ensuring team goals are clearly defined, aligned with business objectives, and effectively communicated to drive focus, engagement, and accountability.
• Enhances governance and management practices to support continuous performance improvement and delivery of QA goals.
• Builds strong cross-functional relationships, acting as a quality advocate and ensuring the Quality agenda is understood, valued, and embedded across the organization.
• Drives talent development through active coaching, mentoring, and tailored growth opportunities, ensuring a strong pipeline of future QA leaders.
• Leads a diverse, inclusive, and empowered QA team that continuously adapts to emerging regulatory, operational, and business needs.

Quality Management

• Ensures the site’s Quality Management System (QMS) remains compliant with global quality and regulatory standards, including FDA 21 CFR Part 820, ISO 13485, MDSAP, and other applicable local and international regulations.
• Oversees all product quality assurance activities at the site, including:
• End-to-end quality oversight across the value stream
• Product testing, batch release, and documentation review
• Quality process control and trending
• Support for field actions and product recalls
• Management and maintenance of site QMS documentation, including policies, SOPs, work instructions, and training records
• Represents QA on the site leadership team and actively contributes to the QARA regional leadership team, aligning site-level quality goals with global objectives.
• Champions a culture of quality, where every employee is accountable for delivering safe, effective, and compliant medical devices that meet patient and customer needs.
• Ensures readiness for and successful execution of internal, third-party, and regulatory audits and inspections.
• Upholds compliance with the clients Code of Conduct and all corporate policies, procedures, and quality standards.
• Performs other duties and special projects as assigned by the immediate supervisor.

EDUCATION / EXPERIENCE REQUIREMENTS:

• Bachelor of Science degree in an engineering, medical or science discipline is a minimum requirement. Advanced degree preferred.
• A minimum of 7 years’ leadership experience in the medical device industry, with at least 12 years’ experience in regulatory and/or quality function(s) commensurate with responsibilities outlined above.
• Extensive experience of compliance with US Quality System Regulation (21 CFR Part 820), Medical Device Directive/Medical Device Regulation and the ISO 13485 quality system requirements.
• Extensive knowledge of quality techniques and practices, as they relate to the medical device industry.
• Track record of developing Organizational capability through people, systems and process development.
• Experience of working in a dynamic, multinational matrix environment.
• Strong business acumen and an ability to influence the direction of the company.
• Audit experience for various regulatory bodies is desirable but not essential.
• High level of English (Native or bilingual proficiency).