MDR Quality Engineer Job Morrisville area,North Carolina USA,Healthcare

Expected Travel

Up to 10%

Requisition

390

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

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

Responsible for preparing updates to technical documentation that are required to meet the EU MDR requirements. Participate and interface with teams to address and execute the transition from the Medical Device Directive to the Medical Device Regulation. Products will include all classifications, i.e. Class I, IIa, IIb and III. The position will require basic knowledge to be capable of interfacing and assessing documents from various departments such as Clinical Affairs, R&D and BU Regulatory Affairs.

The Quality Engineer applies best-practice quality, team-based and statistical tools and techniques, and promotes the value and use of such tools throughout the organization and EU MDR Program.

Principal Responsibilities

Review Design History Files and Technical Files for conformance to MDR requirements and support the Regulatory Department in reviewing technical submissions.

Work with BU regulatory and MDR program work stream leads to ensure technical documentation update timelines are aligned.

Participate in the development of Design Verification and Validation test plans / protocols and provide guidance on Product Requirements compliance. Participate in engineering Design Reviews.

Review, redline, and approve protocols and reports (including biocompatibility protocols, per our new process, in addition to DV, IEC, AA, RTA, ship testing, etc.).

Assist in writing rationales for leveraging certain representative testing for other products SKUs or files.

Remediate risk documentation.

Review and provide input to labels and IFUs.

Review and provide input to PMS and PMCF activities.

Lead usability testing and/or usability rationales.

Provide guidance and direction for sample size and statistical analysis of Verification and Validation testing.

Provide training to project teams on all Quality Policies / Procedures (including verification, validation, statistical methods and design controls), when necessary.

Identify use of appropriate International standards.

Work in coordination with MDR PM to Monitor MDR government agency laws and regulations through websites and publications.

Provide guidance to junior members of the Quality Engineering team as related to the MDR project.

Brings MDR Regulatory Affairs questions/issues to the attention of MDR Project Management team and Business Units leads.

Report out for specific BU project status to Core Team and potentially MDR Steering Committee.

Determine issues which may create regulatory obstacles; investigate and propose solutions.

Adhere to and ensure the compliance of Teleflex’s Code of Ethics, all Company policies, rules, procedures and housekeeping standards.

Education / Experience Requirements

Minimum of a Bachelor’s degree
Minimum of 2-4 years’ experience working in a FDA or ISO regulated environment.
The ideal candidate would have a degree in a scientific discipline such as biology, microbiology,…


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