Expected Travel: Up to 10%
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 will drive compliance for long term Teleflex project to meet EU MDR hazardous materials requirements using strong organizational and project management skills. The Supplier Quality Engineer II, MDR will be a self-directed and influential leader that will work cross-functionally across many disciplines to accomplish project goals. Project Supplier Quality Engineer II, MDR is responsible to establish rapport, build relationships and maintain strong communication and cooperation with company Suppliers. The Supplier Quality Engineer II, MDR is expected to provide supplier quality support in the areas of materials, supplier changes and supplier qualification to exceed all project goals with a timely completion.
• Lead the investigation, resolution, and documentation of Supplier conformance to EU MDR hazardous material requirements.
• Create and maintain strong relationships and effective lines of communication with Suppliers.
• Develop partnerships with Supply Chain, Sustaining Engineering, Design Assurance, Quality Assurance, Project Management, and Manufacturing groups.
• Drive an EU MDR hazardous material assessment project with concise and clear plans that consistently hit project milestones, as well as develop strong contingency plans as part of the project planning process.
• Work cross-functionally, internally and at Suppliers, to identify potential new materials to replace any materials that are non-conforming to EU MDR or to provide justification for use.
• Collaborate with internal EU MDR Team and Suppliers to advise and align on process-validation strategies for new materials and/or components.
• Prepare and negotiate Supplier Quality Agreements with Suppliers, with focus on meeting internal, regulatory, and EU MDR requirements.
• Participate in the selection of new and existing Suppliers to support EU MDR hazardous material requirements.
• Assess and update Supplier files for compliance to internal procedures and requirements.
• Manage, review, and approve Supplier change requests and partner with Sustaining Engineering, Regulatory, and Supply Chain to develop and implement appropriate strategies to support the qualification process and minimize exposure to EU MDR timelines.
• Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Leverage understanding of quality systems and regulatory compliance to achieve project milestones.
• Comply with U.S. Food and Drug Administration (FDA) regulations, EU MDR, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
Education / Experience Requirements
• BA/BS in Engineering or physical sciences
• 3+ years of related experience
Specialized Skills / Other Requirements
• Self-starter with the ability to quickly learn about new processes, projects, and requirements
• Ability to leverage, influence and/or engage others to accomplish projects
• Strong verbal and written communication skills, including the ability to write technical reports / presentations and to negotiate Supplier Quality Agreements
• Solid organizational and follow-up skills, as well as attention to detail
• Critical thinker with analytical problem-solving skills, able to resolve quality-related issues in a timely and effective manner
• Awareness of various process-improvement methodologies, such as Six Sigma and Lean Manufacturing
• Working knowledge of US and international medical device regulations, standards and guidance documents. Including:
o 21 CFR 820 US FDA Quality System Regulations
o ISO 13485:2016 Medical Devices - QMS - Requirements for Regulatory Purpose
o Regulation (EU) 2017/745 Medical Device Regulations
• Preferred ISO 13485:2016 Lead Auditor Certified, or similar Lead Auditor certification (ASQ CQA, for example)
Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities may evolve and change over time.
Teleflex is an equal opportunities employer
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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