MDR Associate Quality Engineer, QA Data Analytics

Date: Jun 14, 2022

Location: Remote (US), NC, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 6565 

 

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

Provide support to the Product Quality Assurance (PQA) and Quality Management System (QMS) teams by processing quality data.  Follow internal procedures to produce quality trends and support review of data and metrics compliant with internal procedures and external standards such as FDA and EU-MDR.  Participate in additional QA projects as required.

Principal Responsibilities

•    Process data and generate presentations that meet requirements of internal procedures and external standards (FDA, EU-MDR, etc). Identify unfavorable trends and support escalation.
•    Query and prepare data from various internal and external sources in support of quality activities. Use Excel to prepare and communicate data logically and effectively.
•    Support monitoring of metrics and effectiveness of quality teams and systems.
•    Use SAP, Agile, and other electronic data and document management systems to store, process, and obtain data.
•    Provide clear and concise written status reports to supervisor or manager keeping them abreast of deliverables and results.
•    Perform “Change Analyst” duties in electronic documentation management system (Agile) as needed.
 

Education / Experience Requirements

•    4-year degree preferred; 1-2 years experience in the medical device industry including knowledge of FDA, EU MDR, and ISO and other related industry regulations desired
•    Background in working with excel required.  Experience with electronic data and document management systems (e.g. SAP, Agile) preferred
 

Specialized Skills / Other Requirements

•    Computer literate (advanced skills in spreadsheet and database applications; comfortable in networked environment)
•    Understanding of best practices for data management and presentation for clarity and ease of use
•    Attentive to detail; good documentation and quality control practices
•    Able to communicate diplomatically and effectively (both verbally and in writing)
•    Able to prioritize projects and adapt to shifting priorities
•    Operate independently with appreciable latitude for actions or decisions on day-to-day activities; seek guidance on anomalies, novel, controversial issues. 
 

 

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.