Expected Travel: Up to 10%
Requisition ID: 6358
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.
OEM - Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
Senior Quality Assurance/Regulatory Affairs (QARA) Engineer will focus on providing quality assurance support to Design and Development projects as well as manage potential regulatory issues associated with the product designs under the supervision of Quality Manager. This will include responsibility for implementing an EU MDR regulatory strategy associated with components and supporting customers strategy for Product Development Process (PDP) projects. The QARA Engineer will also seek out opportunities for improvement in Design and Development as a participant in Design and Development projects in support of corporate Quality objectives
This position will support Design and Development projects for contract manufacturing / Product Development Process (PDP), as necessary, to ensure product quality is achieved and by assessing potential regulatory issues and raising these issues to the Quality Manager, and to consult with Regulatory Affairs. Coaching, mentoring and supporting Associate Engineers or other project team members may be assigned and required.
• Become a source of knowledge for applicable material and product standard, provide training and maintain compliance.
• Champion improvement to the design validation protocol process with focus on simplification, ease of use and error-proofing. Incorporate Design of Experiments (DOE), process FMEAs and other statistical tools within the validation process. Support or conduct product and/or process qualification following changes to manufacturing processes utilizing validation process.
• Support and respond to inquiries on material environmental assessments such as REACH, RoHS, and Conflict Minerals as well as ensure EU MDR material compliance on Design & Development projects
• Implement and support EU MDR regulatory (material compliance) strategy for Teleflex OEM components and assembly products by establishing templates for responding to customer requests as well as working with Supplier Quality resources to ensure compliance requirements are met.
a. This includes creation, revision or collection of associated documentation.
• Provide Design QA and RA support and guidance to contract manufacturing, component and Product Development Process projects as necessary, including product specifications reviews, quality and regulatory strategy development, and quality and regulatory documentation.
• Interface with various internal and external resources such as Manufacturing, Regulatory Affairs, Product Development, Marketing, and Customer Care.
• Adhere to and ensure the compliance of Teleflex's Code of Ethics, all Company policies, rules, procedures and housekeeping standards.
Education / Experience Requirements
• Bachelor's Degree in a scientific field, required.
• ASQ Certified Quality Engineer, preferred
• 6-8 years of Quality or Product Development experience with the following specialized skills, required.
Specialized Skills / Other Requirements
• Quality system development, implementation, and verification
• Skill in the application of quality system and regulatory requirements (ISO 13485, FDA, EU MDR) and for standards for medical device development (, ISO 14971, ISO 10993, ISO 10555, etc.)
• Planning, controlling and assuring product and process quality
• Lean/Six Sigma and problem-solving skills in a manufacturing environment
• CAPA and Nonconformance management
• Reliability and risk management
• Management and leadership
• Ability to coach and supervise a team
• Quantitative methods
• Design and development of medical devices
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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