INGENYX - Quality Engineer 3

Teleflex•Trenton, GA

About The Position

Ingenyx proudly launched as a new, independent company following its divestiture from Teleflex on August 3, 2026. Ingenyx 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. For more information, please visit Ingenyx.com

Requirements

Bachelor’s degree preferred, or equivalent ASQ Certified Quality Engineer certification.
Strong communication and presentation skills required.
3+ years of Quality Assurance experience required.
Manufacturing experience required; regulated or medical industry experience preferred.
Demonstrated experience or success in CAPA and Nonconformance processes
Demonstrated experience or success in Customer complaint investigations
Demonstrated experience or success in Validation concepts and techniques (process, equipment, and test methods)
Demonstrated experience or success in Continuous improvement and project management
Demonstrated experience or success in Process and/or internal auditing
Knowledge of QSR, CFR, cGMP, and ISO regulations required.
Proficiency with Microsoft Word, Excel, and PowerPoint required.
Strong problem-solving skills and experience with Root Cause Analysis tools (6M, Cause-and-Effect, 5 Whys, etc.).
Strong verbal, written, and listening skills.
Strong interpersonal skills and ability to work effectively in a team environment.
Ability to prioritize and adapt to changing priorities.
Ability to work independently with limited supervision.

Nice To Haves

Experience with Minitab and SAP ERP preferred.
Knowledge of statistical techniques preferred (DOE, SPC, Gage R&R).
ASQ Certified Quality Auditor highly preferred.
Design Control and Risk Management experience preferred.

Responsibilities

Nonconformance (NC) and CAPA coordination and processing
Customer complaint investigations
Process and product validations
Customer change-notification evaluations
Internal and external audit support
Quality improvement initiatives
Compliance with Ingenyx and local procedures and policies
Lead Quality activities for Conductor Material Review Board coordination, inspection methods, NC containment/correction/closure, and CAPAs. Analyze trend data and drive improvements.
Lead Conductor complaint investigations, confirmation, and corrective actions. Serve as the primary customer contact for complaint communications and drive improvements based on trends.
Guide and review protocol development, validation execution, and final reports for acceptance.
Lead and participate in short-term product and process improvement projects.
Review, revise, and approve Manufacturing Procedures, Test Method validations, Quality Inspection Plans, and process run sheets.
Perform internal and process audits; participate in vendor audits as needed; and support Back Room activities during FDA and Notified Body audits.
Review Customer Product Specifications. Initiate Engineering Change Notices and review/approve changes as needed.
Conduct QA training certifications for new Production operators.
Support product improvements through quality planning, risk evaluation, and validation.
Perform additional QA responsibilities as assigned by the QA Manager.