Sr. Quality Assurance Manager

Teleflex • Chelmsford, MA

5d

About The Position

The Senior Quality Assurance Manager of the Chelmsford Facility leads the development and execution of strategies to ensure compliance with quality and regulatory standards, while delivering products, services, and processes that meet customer expectations. This role oversees QA operations, drives continuous improvement initiatives, and fosters a culture of quality across the organization. The ideal candidate brings strong leadership, deep quality systems knowledge, and a collaborative mindset to support cross-functional teams and ensure compliance and excellence.

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.
• High level of English (Native or bilingual proficiency).

Nice To Haves

• Audit experience for various regulatory bodies is desirable but not essential.

Responsibilities

• 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 Teleflex 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.
• 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: o End-to-end quality oversight across the value stream o Product testing, batch release, and documentation review o Quality process control and trending o Support for field actions and product recalls o 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 Teleflex’s Code of Conduct and all corporate policies, procedures, and quality standards.
• Performs other duties and special projects as assigned by the immediate supervisor.

Benefits

• medical
• prescription drug
• dental and vision insurance
• flexible spending accounts
• participation in 401(k) savings plan
• paid time off benefits, such as PTO, short- and long-term disability and parental leave

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees