Teleflex · 2 days ago
Sr. Quality Assurance Manager
Chelmsford MA USA
Full-time
Onsite
Senior Level
$159K/yr - $238K/yr
7+ years expTeleflex is a global provider of medical technologies focused on improving health and quality of life. The Senior Quality Assurance Manager leads the development and execution of strategies to ensure compliance with quality and regulatory standards while overseeing QA operations and fostering a culture of quality across the organization.
CommercialHealth CareMedicalMedical Device
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: 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 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
Qualification
Required
Bachelor of Science degree in an engineering, medical or science discipline is a minimum requirement
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)
Preferred
Advanced degree preferred
Audit experience for various regulatory bodies is desirable but not essential
Benefits
Medical
Prescription drug
Dental and vision insurance
Flexible spending accounts
Participation in 401(k) savings plan
Various paid time off benefits, such as PTO, short- and long-term disability and parental leave
Company
Teleflex
Teleflex is a manufacturing company that designs and develops medical devices for the healthcare sector.
10001+ employees
H1B Sponsorship
Teleflex has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (2)
2023 (3)
2022 (2)
2021 (4)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$400M2016-05-12Post Ipo Debt· $400M
1990-01-01IPO
Leadership Team
Liam Kelly
Chairman, President and CEO
Cameron Hicks
Corporate Vice President and Chief Human Resources Officer
Recent News
2025-12-18
2025-12-10
Company data provided by crunchbase