Director, Quality Management Systems
Expected Travel: Up to 10%
Requisition ID: 14034
About Teleflex Incorporated
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, Rusch, 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.
Position Summary
This position reports to the Sr Director, Quality Excellence & Systems. Improve and maintain the global Quality System in line with ISO 13485, Medical Device Directive (MDD), Medical Device Regulation (EU-MDR), MDSAP International Regulations (Australia, Brazil, Canada, Japan, USA) and regulatory requirements applicable to the Quality Management System (QMS). The role will also involve multi-site collaboration with various facilities and departments. Provide regular status reports to management as required.
As a People Manager, you play a pivotal role in leading, developing, and inspiring a high-performing team to deliver exceptional results aligned with organizational goals. You are responsible for building organizational capability through effective talent development, fostering a culture of accountability, and promoting continuous improvement. Your role requires strong cross-functional collaboration to ensure alignment and drive integrated solutions across the business. As a leader, you are a visible champion of our culture and values, creating an inclusive, purpose-driven environment where individuals feel empowered to contribute and grow.
Principal Responsibilities
Plan and manage the duplication and certification of the QMS during the divestiture
Own and liaise with eQMS vendor, systems team, and global process owners to manage divestiture and subsequent system integrations (e.g., PLM, ERP) as needed
Direct facilities (Athlone, Morrisville, Pleasanton, Santa Barbara, and others as assigned) and their Quality Management Representatives and ensure the QMS is consistently established, implemented, and maintained
Partner with Regulatory Affairs and communicate with Notified Bodies and regulators with respect to certificates, audits, and QMS elements as necessary
Support quality system and regulatory audits including by not limited to FDA, Notified Body ISO 13485/MDSAP/EU MDR, Customer and Internal audits
Develop, implement and monitor key metrics used to assess Quality System Execution
Support change control activities including reviewing and approving QMS documentation, supporting impact assessment, and attending technical reviews to provide feedback on QMS processes
Develop, enact, and maintain the global QMS certificate strategy for the enterprise
Ensure alignment between the Global QMS and facilities local QMS
Ensure consistency between the design center QMS and activities
Lead Strategic QA Projects
Establish function specific quality objectives, create quality planning documentation when necessary and lead a continuous monitoring process for the facilities based on inputs from relevant stakeholders
Manage budgetary requirements and ensure compliance of expenditures to meet budget
Build interdependent relationships with R&D, Marketing, Operations and RA and Administration
Support the Global Corrective Action and Preventive Action (CAPA) program by reviewing and approving Global Quality Management System CAPAs and participating in the executive CAPA Review Board (eCRB) as the Quality Management Systems representative
Participate in mergers and acquisitions providing due diligence and Quality support
Support and lead additional activities as assigned by Sr. Director, Quality Excellence & Systems or Executive Leadership
Education / Experience Requirements
Bachelor of Science (preferred in Engineering, Microbiology or other technical degree)
Experience Managing the Quality Management Systems and medical device regulations
Experience with regulatory inspections/audits
Experience with Project Management
Experience and knowledge of process risk management and CAPA systems
Excellent organizational skills
Excellent written and verbal communication skills
Excellent stakeholder management skills
Specialized Skills / Other Requirements
Certified Quality Manager preferred
PMP certification preferred
Experience with Veeva preferred
TRAVEL REQUIRED: 10%
WORKING ENVIRONMENT:
Office/Professional Plant/Manufacturing Remote/Field Laboratory
#LI-PD1
Teleflex is an equal opportunity employer. Applicants will be considered without regard to age, gender, race, nationality, ethnicity, civil status, family status, sexual orientation, disability, religion and/or membership of the traveller community.
If you require accommodation and support to apply for a position, please contact us at [email protected].
Diversity fosters innovative thinking and entrepreneurship and that's what we are about at Teleflex. We trust and value our people and their diversity and we make it fun to work here. We are on a journey to ensure our workplaces mirror the patients we serve and the communities we operate in. Our approach is simple, we embrace everyone and want them to feel they belong here. We are building a culture where all employees can bring their best and unique selves to work. If that appeals to you, we would love to hear from you. Come join a company where diversity is sought out and inclusivity is how we progress.
At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.
Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rusch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
2026 Teleflex Incorporated. All rights reserved.
