Senior Quality Engineer, MDR
Teleflex

Job Info

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Expected Travel: None

Requisition ID:3499

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.

Position Summary

Thoroughly 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. Thoroughly understands and applies statistical methods to product and processes through the Product Design and Development process. This position interfaces with crossfunctional teams to complete sustaining projects, design control deliverables, and activities to ensure Teleflex Medical OEM suture products meet evolving standards in the European Union (EU). Scope will also include sustaining and remediation activities to ensure proper data is on file to support EU MDR informaiton required by contract manufactured, sterile and non-sterile component customers. 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 prepartion for new 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 limited supervision. Provide supervisory responsibilities on projects for technicians as required or directed by the Quality Manager
• Authors protocols or, 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 statistacally 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
• Provide support to Post Market Surveillance activities representing Quality as necessary
• Works closely with technology personnel in understanding, developing and executing statistically designed experiments
• Works closely with with all crossfunctional team members in onboarding or maintaining supplier files during MDR remediation as well as routine maintenance of all supplier files
• Ensure full compliance with quality and regulatory requirements

Education / Experience Requirements

• Bachelors Degree required. Prefer focus in engineering, life science or related discipline
• 5 years minimum related quality experience in a manufacturing environment
• Knowledge of EU MDR requirements for medical device manufacturer required
• Experience in the medical device industry, Design and Development Process, and EU MDR preferred
• Broad experience in manufacturing operations, including new product development and implementation, process qualification, cost reduction and quality engineering
• Prefessional Certification, ie 6 Sigma black belt, ASQ - CQA, CQE and/or CRE; RAB preferred
• Strong regulatory, cGMP, QSR, ISO knowledge base

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
• Ability to use and apply statistical skills, such as DOE, SPC, Reliability, Gage R&R
• 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
• Ability to travel domestically

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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