Quality Engineer I - Product Safety and Risk

Date: Feb 21, 2021

Location: Chelmsford, MA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 3274 

 

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 Functions The Corporate division is the central operating unit of the company; setting strategy and policy and providing business development, finance, human resources, information technology, investor relations and legal support to the businesses. The global Company headquarters is located just outside of Philadelphia in Wayne, PA. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

Evaluates product safety and risk to make decisions on MDR Medical Device Reporting, fully documenting those decisions. Files MDR's when needed and communicates to management, clinical medical affairs and legal, as required. Prepares risk evaluations and trend analysis reports. Facilitates and conducts moderate to complex investigations. Works cross-functionally to determine key product characteristics/specifications associated with complaint root cause analysis and associated investigation. Escalates product quality concerns to Manager to pursue Corrective/Preventative Action(s) required. 

Principal Responsibilities

•    Review and approve MDR decision trees and provide written rationale for non-reportable complaints
•    Assist with monitoring, analyzing and presenting monthly complaint trend analysis 
•    Uses critical thinking concepts to determine complaint root cause
•    Provide detailed database reports and status information, as required
•    Review and summarize results of Quality Engineering investigations to ensure accuracy
•    Analyze product complaints and samples. Confirms complaint and determines root cause where possible.
•    Document root cause investigation in a clear and concise manner
•    Review product specifications to determine and document inspection criteria related to root cause analysis
•    Processes returned complaint sample in complaint lab
•    Interface with a variety of internal and external customers including: Manufacturing, Marketing, R&D, and Regulatory
•    Assist with Audits of Post Market Surveillance (FDA, ISO, Internal, Customer)
•    Document 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 Biomedical Engineering 
•    Experience performing root cause analysis of technical discrepancies, abnormalities, and product non-conformance's preferred
•    Experience preparing laboratory documentation (e.g. laboratory procedures, analysis spreadsheets, reference documents, and others) in a variety of formats including Word, Excel, and Power Point a plus
•    Clinical Engineering background preferred 
 

Specialized Skills / Other Requirements

 •    Strong project planning and time management skills focused on meeting customer needs
 •    Self-directed and self-motivated
 •    Experience working in a lab environment utilizing microscopes
 •    SAP experience a plus
 •    Strong analytical and writing skills
 •    Maintains a cooperative and motivation attitude with co-workers
 

 

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.


Nearest Major Market: Boston