Quality Assurance Engineer

Date: Feb 19, 2021

Location: Exton, PA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 3458

 

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

Under general direction, responsible to perform the Quality Assurance and Quality Engineering functions supporting the site. Shall organize and manage multiple projects and ensure assigned deliverables are completed in a timely manner.  

Principal Responsibilities

•    Analyze manufacturing quality data and identify areas for improvement, efficiency, and cost reductions.  Lead and/or support initiatives as agreed upon by management. 
•    Perform Non-Conforming Product and CAPA investigations. Perform root cause analysis, recommend, and implement corrective actions and material dispositions. Ensure Investigations are closed in a timely manner. 
•    Support and evaluate current test and inspection methods to identify areas for continuous improvement. 
•    Authors protocols or, provides support in performing Installation Qualification (IQ), Operation Qualification (OQ), and Process Qualification (PQ) validation protocols.  Provides statistically valid sampling plans when required.
•    Support the quality technicians with the testing of product when needed and author quality inspection procedure creations or changes when required.
•    Assist quality technicians with review and analysis of test results as needed. 
•    Support supplier quality and serve as technical interface between Exton site and supply chain (subcontractors, suppliers, and service providers) 
•    Support Supervisor with Quality System enactments and deliverables as requested.  
 

Education / Experience Requirements

•    Bachelor’s  or Master’s Degree in Biomedical or Mechanical Engineering preferred; however, other relevant engineering, science or technical degrees will be considered. 
•    Professional Certifications such as 6 Sigma black belt, ASQ – CQA, CQE and/or CRE; RAB preferred. 
•    1-3 years of experience in manufacturing quality operations including Quality Engineering, manufacturing quality data analysis and statistical techniques. 
 

Specialized Skills / Other Requirements

•    Proficient technical writing skills 
•    Strong attention to detail and ability to meet deadlines
•    Demonstrated ownership of workload and deliverables
•    Able to proactively communicate status/updates of tasks and seek support when needed
•    Experience in methodologies for root cause investigation 
•    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.
•    Ability to operate with appreciable latitude for actions or decisions on day-to-day activities.
•    Ability to define problems, collect data, establish facts, and draw valid conclusions.
•    Strong understanding of industry regulations such as ISO13485 and FDA QSR’s.
 

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: Philadelphia