Associate Quality Engineer, QA Data Analytics

Date: Nov 24, 2021

Location: (Remote, US), NC, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 5165

 

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

Provide support to the Product Quality Assurance (PQA) and Quality Management System (QMS) teams by processing quality data and documents for special projects.  Follow internal procedures, Quality Agreements and Quality Plans to ensure compliant storage and transfer of Quality System documentation and data.  Participate in additional QA projects as required.

Principal Responsibilities

•    Support data requests related to special projects, including but not limited to site transfers, by extracting data (e.g. complaints, NCs, etc.) from SAP or processing via excel at the direction of manager 
•    Support documentation requests as needed for special projects.  Extract QMS documents and records from Agile (e.g. Device History Files, Bills of Materials, Standard Operating Procedures)
•    Receive, process and import documents and records into Agile from sister sites for integration and/or records retention.  
•    Provide clear and concise written status reports to supervisor or manager keeping them abreast of deliverables and results.
•    Perform administrative duties and document review in electronic documentation management system (Agile) as needed.
•    Process data for presentation and/or distribution to a variety of cross-functional audiences.
 

Education / Experience Requirements

•    4-year degree preferred; 1-2 years experience in the medical device industry including knowledge of FDA 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

•    Advanced skills in spreadsheet and database applications; comfortable in networked environment
•    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 or novel 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.