Associate Quality Engineer
Teleflex

Expected Travel: Up to 10%

Requisition ID: 5170

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

Develops processes and associated documentation to support complaint investigations. Decontaminates samples using a variety of methods following departmental procedures. Works closely with manufacturing sites and R&D to understand and document key product characteristics/specifications to assist with complaint root cause analysis and associated investigation. Conducts product complaint investigations using typical lab equipment (e.g. microscope and camera, leak tester, gage pins, gages, computer) and writes investigation in a clear and concise manner that can easily be conveyed through a customer letter.

Principal Responsibilities

• Decontaminates complaint samples using methods defined per departmental procedures
• Performs device history record review of products where applicable per departmental procedures
• Able to use critical thinking concepts to determine complaint root cause
• Maintains a cooperative and motivated attitude with co-workers
• Ability to provide written and oral reports to supervior or manager to keep them abreast of activities and results
• Analyzes product complaints and samples. Confirms reported complaint and determines root cause where possible.
• Documents root cause analysis and investigation in a clear and concise manner
• Reviews product specifications to determine and document inspection criteria related to root cause analysis
• Processes returned complaint sample in complaint lab
• Interfaces with a variety of internal and external customers including: Manufacturing, Marketing, R&D, and Regulatory
• Documents lab and investigations processes according to established guidelines
• Uses SAP to perform complaint trend analysis, and to update complaint investigation

Education / Experience Requirements

• B.S. Degree in engineering, science, or technical discipline preferred; however, will consider equivalent work experience
• 0-1 year experience performing root cause analysis of technical discrepancies, abnormalities, and product non-conformances a plus
• 0-1 year experience preparing laboratory documentation (laboratory procedures, analysis spreadsheets, reference documents, and others) a plus
• Experience working in an FDA regulated environment preferred.
• Experience utilizing SAP for data trend analysis ideal.
• Experience utilizing statistical tools in Excel

Specialized Skills / Other Requirements

• Experience working in a lab environment utilizing microscopes
• Ability to adapt to a variety of software applications required to perform investigations
• Prior Teleflex experience (e.g. Internship) a plus
• Strong analytical and writing skills

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.