Quality Assurance Engineer, II

Date: Jun 1, 2021

Location: Chelmsford, MA, US

Company: Teleflex

Expected Travel: None

Requisition ID: 4044

 

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.

 

Interventional - The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner® and Turnpike® Catheters, AC3 Optimus™ Intra-Aortic Balloon Pump and OnControl® Powered Bone Access System. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

This position provides Quality Engineering support to the Quality Management System for the Chelmsford site. The primary purposes and objectives include:
•    Nonconformance and Corrective & Preventive Action coordination and processing.
•    Support the Incoming & In-Process Inspectors with Nonconformance Activities.
•    Provide input and gather data for the monthly Quality System Review Board (QSRB).
•    Provide input and gather data for the quarterly Quality Management Reviews (QMR).
•    Support the Value Stream as a Quality Engineer (QE) on NC and CAPA investigations.
•    Support the Value Stream as a Quality Engineer with risk evaluation and field corrective actions (EIF) as needed.
•    Internal & external auditing responsibilities and support. 
•    Support the training department as needed.
•    Quality improvement projects; and 
•    Maintain compliance with Teleflex Global & local procedures and policies.
 

Principal Responsibilities

•    Nonconformance (NC) and CAPA processing – lead quality activities such as inspection methods, NC containment, correction, closure and CAPAs; and drive improvement through analysis of trend data. 
•    Support Incoming & In-Process Inspection teams.
•    Prepare QSRB and QMR slides as needed.
•    Support the Value stream with investigations required for field corrective actions including risk evaluation.
•    Perform internal audits and support supplier corrective actions as needed.
•    Quality & Cost Improvement Projects – lead and participate on key short-term projects on product or process improvements;
•    Production & Process Controls – review, change and approve manufacturing procedures; test method validations; Quality Inspection plans and Process run sheets 
•    Auditing – routinely perform internal and process-related audits. Participate in vendor audits if necessary. Support the Back Room during regulatory and notified body audits. 
•    Documentation Control – perform change controls (ADC/ECOs) as needed. 
•    Training – Perform QA training certifications on new production operators as needed.
•    Support Engineering with new product development with quality planning, risk evaluation and validation. 
•    Perform any additional QA tasks, as assigned by QA Manager or Plant Manager. 

Education / Experience Requirements

•    Knowledge of QSR, CFR, cGMP, and ISO regulations (required)
•    Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint is required. 
•    Experience with Minitab and SAP, ERP is preferred. 
•    Working knowledge and/or experience with SAP and AGILE strongly preferred.
•    Statistical Techniques preferred (DOE, SPC, and Gage R&R).
•    Problem solving skills and experience with Root Cause Analysis tools (6M, Cause-Effect, 5Ws etc)
•    Good listening, verbal and written communication skills 
•    Excellent interpersonal skills with a demonstrated ability to work in a team environment.
•    Ability to prioritize and adapt to shifting priorities.
•    Ability to work independently with limited supervision.
 

Specialized Skills / Other Requirements

 

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