Quality Engineer II

Date: Feb 12, 2024

Location: Trenton, GA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 9838


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 provides Quality Engineering leadership to Conductor manufacturing as the lead Quality member on the team. The primary purposes and objectives include:
•    Nonconformance and CAPA coordination and processing; 
•    Customer complaint investigations;
•    Process & product validations;
•    Customer Notification of Change evaluations;
•    Internal & external auditing responsibilities and support; 
•    Quality improvement projects; and 
•    Maintain compliance with applicable Teleflex Global & local Procedures and Policies

Principal Responsibilities

•    Nonconformance (NC) and CAPA processing – lead quality activities with respect to Conductor Material Review Board coordination; inspection methods, NC containment/correction/closure and CAPAs; and drive improvement through analysis of trend data. 
•    Customer Complaint Investigations – Primary investigator and facilitator for Conductor complaint investigation, confirmation and corrective actions. Act as primary customer contact on complaint communications. Drive improvement based on trends.
•    Process Validations – guide and review protocol development, validation implementation and report review an acceptance;
•    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 FDA and Notified Body audits. 
•    Documentation Control – perform Customer Product Specification reviews. Initiate Engineering Change Notices and review/approve as needed.
•    Training – Perform QA training certifications on new Production operators.
•    Support Engineering with improving Product with quality planning, risk evaluation and validation. 
•    Perform any additional QA tasks, as assigned by QA Manager.

Education / Experience Requirements

•    Bachelor degree is preferred or the equivalent ASQ Certified Quality Engineer certification. 
•    5+ years of Quality Assurance experience required. 
•    Experience in a manufacturing environment, with preference in a regulated or medical industry.
Additional experience and proven success in the following area or skill: 
•    CAPA and Nonconformance process
•    Customer Complaint Investigations
•    Validation concepts & techniques (process, equipment, and test methods)
•    Continuous Improvement Process/Project Management
•    Process or internal auditing.

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)
•    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
•    ASQ Certified Quality Auditor highly desired
•    Design Control and Risk Management experience desired

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: 877-880-8588 or Talent@Teleflex.com.

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