Address
Form of workExpected Travel: Up to 10%
Requisition ID: 9420
About Teleflex Incorporated
Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation - a relentless pursuit of identifying unmet clinical needs - to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. 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.
Support multiple functions through maintaining and improving an effective and compliant Quality System.
Manage assigned portions of the Quality System to ensure overall system effectiveness.
Responsible for quarterly Management Review preparation and execution
Provide training and mentorship to NCE owners
Identify opportunities to continuously improve the Quality System processes.
Responsible for identifying, implementing, and reporting metrics to site leadership
Ensure processes needed for the NCE system are documented and controlled.
Maintain effective, efficient, and cohesive Quality System processes which ensure compliance with internal requirements, as well as external (FDA, ISO, etc.) requirements and expectations.
Develop, implement, and maintain meaningful NCE/CAPA metrics to measure the Quality System performance.
Supports organization and facilitation (front and back room) of FDA, Notified Body, and Supplier audits and inspections.
Support Management Review activities.
Responsible for site External Standards process
Partners with Regulatory and/or departments to execute compliance-related strategies.
Partners with technical teams to ensure Quality System enables success while maintaining compliance.
Initiate, prioritize, and lead optimization opportunities to increase effectiveness and efficiency.
Implement corporate strategic initiatives and execute at a site level.
Bachelor's Degree required
One to three years of relevant experience required
Ability to lead cross-functional teams for project execution.
Effective verbal and written communication.
Proficient in technical / systems writing and review.
Possess interpersonal skills to work in a team and as an individual contributor.
Ability to collaborate with personnel at all levels both within and outside the company.
Structured and methodical problem-solving approach.
Understanding of medical device industry Quality System design and management.
Experience with FDA Quality Systems Regulations, ISO 13485, Quality Certificates, GMP, MDSAP, and EU MDR.
Ability to foster a positive culture of growth, collaboration, and achievement across the organization.
Lead or support Quality Systems projects to support compliance to standards.
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Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or Talent@Teleflex.com.
Teleflex is the home of Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rusch, UroLift and Weck - trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rusch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
