Sr. Manager, Quality Systems
Teleflex

Job Info

Expected Travel: Up to 10%

Requisition ID:3710

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.

Position Summary

This position reports to the Director, Quality Systems. Improve and maintain the 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 Teleflex Medical offices in addition to other departments. Provide regular status reports to management as required.

Principal Responsibilities

• Act as Quality Management Representative at the Morrisville, NC location to:
o ensure that processes needed for the QMS are documented
o ensure the QMS is established, implemented, and maintained
o report to top management on the effectiveness and performance of the QMS and any need for improvement
o promote awareness of customer, regulatory and QMS requirements throughout the organization including but not limited to ISO 13485, EU Medical Devices Directive, EU Medical Device Regulation, Japan PMD Act, Canada SOR/98-282, US21CFR820, Brazil RDC 16/2013, and Australia ARGMD
• Responsible for Regulatory Compliance (PRRC) with responsibility for; the conformity of the devices is appropriately checked, in accordance with the QMS under which the devices are manufactured before a device is released.
• Lead and manage the development and deployment of a world-class quality system that meets corporate objectives within the applicable regulations.
• Lead and direct quality system and regulatory audits including but not limited to FDA, Notified Body ISO 13485/MDSAP/EU MDR, Customer, and Internal audits.
• Ensure alignment between the Morrisville Quality Management System and Global Quality Management System.
• Responsible for QS elements, including but not limited to; NC, CAPA, Change Management and Document Control, Records Control, Management Review, Audits
• Coordinate communication with Notified Body relating to QS elements
• Coordinate and lead Management Review
• Lead Strategic QA Projects
• Manage facility personnel in quality-related technical principles, including but not limited to Problem Solving (Root Cause Analysis, DOE, FMEA, etc.)
• Establish site-level quality objectives, create quality planning documentation when necessary and lead a continuous monitoring process for the Morrisville Quality System based on inputs from relevant stakeholders.
• Responsible for developing, implementing and monitoring of key metrics used to assess Quality System Execution.
• Participate in mergers and acquisitions providing due diligence and Quality support
• Manage budgetary requirements and ensure compliance of expenditures to meet budget.
• Build interdependent relationships with R&D, Marketing, Operations and RA and Administration.

Education / Experience Requirements

• Bachelor of Science in Engineering, Microbiology or other technical degree.
• Experience with Quality Management Systems and medical device regulations
• Experience with regulatory inspections/audits

Specialized Skills / Other Requirements

• Experience and knowledge of risk management and CAPA systems
• Excellent organizational skills
• Excellent written and verbal communication skills
• Experience and knowledge of six sigma and cost of quality tools and techniques (preferred)
• Certified Quality Manager (preferred)

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: 262-439-1894.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® - trusted brands united by a common sense of purpose.Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

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