Sr. Supplier Quality Engineer

Date: Nov 17, 2020

Location: Maple Grove, MN, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 3054

 

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.

 

Interventional - The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner® and Turnpike® Catheters, AC3 Optimus™ Intra-Aortic Balloon Pump and OnControl® Powered Bone Access System. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

This position is responsible for overall Supplier Quality Management at Vascular Solutions, including qualification, issue resolution, change management, and performance monitoring of Suppliers within a highly regulated Medical Device manufacturing environment.

Principal Responsibilities

•    Create and maintain strong relationships and effective lines of communication with Suppliers
•    Develop partnerships with Supply Chain, R&D, Design Assurance, and Manufacturing groups
•    Lead the investigation, resolution, and prevention of supplied component nonconformances
•    Trend data, identify improvement projects, and work with the Manufacturing organization, Supply Chain, and Suppliers to implement improvements in components (increase capability, reduce scrap, improve/repair processes, etc.) and supplier performance
•    Initiate and follow-up Supplier Corrective Actions (SCARs) in partnership with impacted cross-functional groups to ensure complete and effective root cause analysis and corrective action implementation
•    Perform periodic audits of Supplier quality systems to assure continued Supplier conformance to the quality system requirements
•    Manage, review, and approve Supplier change requests and partner with Sustaining Engineering, Regulatory, and Supply Chain to develop and implement appropriate strategies to support qualification through the change approval process 
•    Recommend and drive continuous improvements in the Supplier Quality organization, to improve the related systems and processes in Vascular Solutions
•    Prepare and negotiate Quality Agreements with Suppliers
•    Assess potential new Suppliers for technical, quality, and manufacturing capabilities
•    Lead cross-functional projects with concise and clear plans that consistently hit project milestones, as well as develop strong contingency plans as part of the project planning process
•    Review new design specifications and propose changes to existing specifications to support component quality and manufacturability
•    Collaborate with Suppliers to develop comprehensive process-validation strategies
•    Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
•    Initiate and lead change orders, deviations, and investigations to maintain compliance
 

Education / Experience Requirements

•    BA/BS in Engineering or physical sciences
•    5 years of related experience
 

Specialized Skills / Other Requirements

•    Self-starter with the ability to quickly learn about new processes, projects, and requirements
•    Strong verbal and written communication skills, including the ability to write technical reports/presentations and to negotiate Supplier Quality Agreements
•    Solid organizational and follow-up skills, as well as attention to detail
•    Critical thinker with analytical problem-solving skills, able to resolve quality-related issues in a timely and effective manner
•    Knowledge of quality-related tools including, but not limited to, SPC, DOE, TMV, and Quality Systems
•    Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), EU MDR, and ISO 13485:2016 
 

 

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.

© 2020 Teleflex Incorporated. All rights reserved.


Nearest Major Market: Minneapolis