MDR Quality Engineer

Date: Apr 3, 2021

Location: Morrisville, NC, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 3350

 

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.

 

Respiratory - Patients and caregivers around the world rely on Teleflex and the Hudson RCI® brand of respiratory products to make breathing easier. Guided by the voice of the clinician, Teleflex strives to advance patient care by focusing on improving patient outcomes while delivering caregiver efficiency. By incorporating the needs of the caregiver into every product we develop, our goal is to advance patient safety and, ultimately, achieve the best patient outcome possible. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

The MDR Quality Engineer is responsible for preparing updates to technical documentation that are required to meet the EU MDR requirements. The incumbent will assess documents and execute the transition from the Medical Device Directive to the Medical Device Regulation and will focus on Respiratory products in all classifications. 
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 Respiratory Business Unit (BU) Regulatory Affairs 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, 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 and 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.
•    Bring 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

•    Bachelor's degree, preferably in a scientific discipline such as biology, microbiology, chemistry, engineering, or medical technology.  
•    Minimum 2 years experience working in a FDA or ISO regulated environment.
•    Experienced in the skillful preparation of risk management and design verification and validation documentation. 

Specialized Skills / Other Requirements

•    Working knowledge of international requirements and quality systems.
•    Orientation for detailed work with emphasis on accuracy and completeness
•    Effective written and oral communication skills
•    Good organizational and planning skills; drives for results
•    Effective analytical/problem solving skills
•    Good interpersonal skills that include working well in a team environment and the ability to lead others.
•    Ability to exercise reasonably independent judgment and discretion within a defined range of policies and practices.
•    Ability to handle multiple tasks and to prioritize/schedule work to meet business needs with routine supervision.
•    Intermediate knowledge of Microsoft Office suite including Outlook, Word, Excel, PowerPoint

 

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.

© 2021 Teleflex Incorporated. All rights reserved.


Nearest Major Market: Raleigh