Senior Quality Engineer

Date: Nov 17, 2023

Location: Trenton, GA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 8674


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


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 will provide technical support and take a leadership role in quality engineering functions in manufacturing and product development in compliance with FDA 21CFR Part 820, ISO 13485, and internal procedures.

Principal Responsibilities

•    Support product and process validation, design change and review, quality planning, and risk evaluation.
•    Supervise Quality Assurance Inspectors if needed.
•    Coordinate Corrective and Preventive Action (CAPA) for customer, internal, and vendor related needs.
•    Audit internal and vendor processes and procedures.
•    Participate in Continuous Improvement Projects (CIP) for both processes and business systems.
•    Direct quality activities in manufacturing such as inspection methods and Material Review Board (MRB).
•    Develop training programs for inspection and engineering.
•    Represent company during customer or regulatory audits as needed.

Education / Experience Requirements

•    Must have a B.S. (technical degree preferred) 
•    Minimum 7-8 years QA engineering experience in a medical device manufacturing environment
•    ASQ certification highly desired

Specialized Skills / Other Requirements

•    Validation concepts & techniques (process, equipment, and gauging)
•    Regulatory cGMP, QSR and ISO knowledge base
•    Computer literate (MS Word, Excel, Access, PowerPoint, and Mini-tab preferred)
•    Negotiation and problem solving skills
•    Good oral and written communication skills
•    Statistical Skills (DOE, SPC, Reliability, Gage R&R)
•    Experience with risk analysis methodologies
•    Experience in the area of manufacturing operations
•    Ability to prioritize and work independently
•    Experience developing training programs
•    Able to work independently with limited supervision
•    Exposure to high production/output machinery and equipment, and constant noise in the production/plant environment. Engages in walking, sitting, lifting, bending, carrying, talking, and hearing
•    The job description documents the general nature and level of work but is not intended to be a comprehensive list of all activities, duties, and responsibilities required of job incumbents. Consequently, job incumbents may be asked to perform other duties as required.


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.

Nearest Major Market: Chattanooga