Senior Quality Engineer

Date: Nov 16, 2021

Location: Jaffrey, NH, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 4912

 

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.

 

OEM – Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. 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 shall apply quality assurance concepts to eliminate process or material/product deficiencies to improve quality, reduce costs and optimize product performance. 
This position will support compliance of the Quality Management System (QMS) and work within a collaborative team environment to influence and inspire change and achievement of Quality and Business Objectives.
This position provides Quality Engineering leadership to manufacturing as a lead Quality member and supports Manufacturing Transfers and New Product Introduction.
 

Principal Responsibilities

•    Lead and support Quality improvement projects in support of proactive Quality and CIP initiatives
•    Lead and support Quality System remediation activities
•    Lead and respond to Customer Info Requests
•    Process Validations – guide and review protocol development, validation implementation and report review an acceptance
•    Test Methods – creation of Test Methods for inspection improvement and/or specification alignment, generation and execution of associated Test Method Validations
•    Quality & Cost Improvement Projects – lead and participate on key short term projects on product or process improvements
•    Auditing – routinely perform internal and process-related audits. Participate in vendor audits if necessary. Support the Front Room/Back Room during Customer, FDA, and Notified Body audits. Act as external audit host as needed
•    Support Engineering with New Product Development and Manufacturing Transfers with quality planning, risk evaluation and validation
•    Risk Management – generate and revise manufacturing Failure Mode Effects Analysis documentation
•    Adhere to and ensure the compliance of Teleflex’s Code of Ethics, all Company policies, rules, and procedures
•    Perform any additional QA tasks, as assigned by QA Manager
 

Education / Experience Requirements

•    Bachelor degree in scientific, technical, or engineering or the equivalent ASQ Certified Quality Engineer certification is required
•    5+ years of Quality Assurance experience required
•    Experience in a manufacturing environment, with preference in a regulated or medical industry
•    Certified Quality Auditor highly desired
 

Specialized Skills / Other 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 desired
•    Statistical Techniques desired (DOE, SPC, Gage R&R)
•    Problem solving skills and experience with Root Cause Analysis tools (6M, Cause-Effect, 5Ws etc)
•    CAPA and Nonconformance process
•    Validation concepts & techniques (process, equipment, and test methods)
•    Continuous Improvement Process/Project Management
•    External and internal auditing processes
•    Risk Management processes
•    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 is desired
•    Ability to work independently with limited supervision
 

 

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: Bellows Falls
Nearest Secondary Market: Keene