Quality Engineer, MDR
Teleflex

Job Info

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Expected Travel: None

Requisition ID:4356

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

Understands fundamentals of the FDA and ISO quality systems, details of specifications, and related quality standards and ensures that all necessary systems, details of specifications, and related quality standards are in place and effective. Understands and applies statistical methods to product and processes characteristics. This position interfaces with cross-functional teams to accomplish the main responsibilities and to ensure Teleflex products meet evolving standards in the European Union (EU). The scope will also include sustaining and remediation activities to ensure proper data is on file to support EU MDR information. Ensures supplier controls are implemented per the required procedures and documentation supports EU MDR.

Principal Responsibilities

• Work within a crossfunctional team to create and/or update documentation to support Design Control, Technical Files and Design Dossiers in preparation for MDR requirements
• Reports on status and progress of EU MDR projects as required
• Provides support for product/process specifications, standards, and required quality systems to support EU MDR implementation and documentation. Writes/revises procedures and specifications as necessary
• Works on assigned EU MDR projects under supervision.
• Provides support in performing Installation Qualification (IQ), Operation Qualification (OQ), and Process Qualification (PQ) validation protocols in support of EU MDR design control deliverables. Provides statistically valid sampling plans when required
• Partners with affiliated disciplines, (ie Regulatory Affairs, Quality Engineering, New Product Development, Operations, Supplier Management) through the Product Design and Development Process to assure that adequate design controls and/or procedures are complied with and met
• Provides support to Post Market Surveillance activities representing Quality as necessary
• Ensures full compliance with quality and regulatory requirements
• Performs any additional QA tasks, as assigned by QA Manager

Education / Experience Requirements

• Bachelors Degree required. Prefer focus in engineering, life science or related discipline
• 2-3 years of Quality Assurance and/or Quality Systems experience required.
• Knowledge of EU MDR requirements for medical device manufacturers is preferred
• Experience in the medical device industry is required

Specialized Skills / Other Requirements

• Proficient with Microsoft Office, including Word, Excel, Powerpoint and Outlook (ie database development, statistical software and analysis, simulation, word processing for report generation, etc.)
• Fluent in spoken and written English
• Excellent negotiation, problem solving and project management skills
• Strong attention to detail and ability to meet deadlines
• Outstanding written and verbal communication skills including the ability to effectively communicate with a broad spectrum of people with varying backgrounds, education and experience
• Strong reasoning ability to support and prioritize projects, adapt to shifting priorities, work with minimal supervision, and ability to resolve problems/conflicts
• Ability to operate with appreciable latitude for actions or decisions on day-to-day activities. Receives guidance on novel or controversial situations
• Ability to define problems, collect data, establish facts, and draw valid conclusions
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
• Ability to work in a fluid, demanding environment

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.

© 2021Teleflex Incorporated. All rights reserved.

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