Post-Market QA Engineer II

Date: Jan 13, 2021

Location: Maple Grove, MN, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 3103

 

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 will perform thorough and accurate product complaint investigations and root cause analysis for medical devices used in interventional cardiology and radiology procedures. The position will engage cross-functional engineering and clinical support and effectively communicate important findings and trends. 

Principal Responsibilities

•    Drive thorough and accurate product complaint investigations to timely completion, including escalation as needed.
•    Apply engineering judgment and product knowledge to assess returned devices, complaint details, and coordinate clinical review.
•    Document work performed in a clear, consistent manner that demonstrates compliance with applicable regulations.
•    Proactively engage cross-functional engineering team members to support root cause investigations.
•    Utilize product documentation to identify impacted requirements/specifications and drive investigative activity.
•    Decontaminate and analyze returned devices, and arrange for testing or external analysis as needed.
•    Support investigation into complaints of company-distributed or supplier-manufactured products/components, working with internal and external contacts to facilitate their investigations.
•    Participate in regulatory body audits and internal audits as a subject matter expert on complaint investigations. 
•    Identify informational needs during investigation and escalate to other functional areas.
•    Identify signals or trends and compile relevant information to support internal decision-making.
•    Identify opportunities and take initiative to improve effectiveness and efficiency of quality system processes.
•    May support non-conforming event process, CAPA investigations related to product complaints, and review of manufacturing records and processes for relevant data.
•    May perform database/system functions to coordinate monitoring programs and produce accurate reports.
•    Individually contribute to project teams for Quality Assurance department projects.

Note: 0% of this job involves direct R&D activities.
 

Education / Experience Requirements

•    BA/BS in Engineering, physical sciences, or equivalent field; OR relevant clinical credentials  
•    3 years experience in the medical device industry, or 2 years of clinical experience
 

Specialized Skills / Other Requirements

•    Prior clinical experience strongly preferred
•    Prior experience in medical device Quality Assurance or performing root cause investigations
•    Experience in methodologies for root cause investigation
•    Able to proactively communicate status/updates of tasks and seek support when needed
•    Demonstrated ownership of workload and deliverables
•    Experience providing direction to extended team members 
•    High level of attention to detail
•    Effective at verbal and written communication at different levels within the organization 
•    Proficient in technical writing and interpretation of clinical and technical data
•    Strong interpersonal skills, with demonstrated ability to work effectively within a team and as an individual contributor 
•    Proficient with MS office programs 
•    Foster a positive culture of growth, collaboration, and achievement across the organization.
 

 

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