Sr. Quality Assurance Manager

Teleflex•Chelmsford, MA

4d•Onsite

About The Position

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare. Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ - trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com. Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.Position Summary 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 streamo Product testing, batch release, and documentation reviewo Quality process control and trendingo Support for field actions and product recallso 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.