INGENYX - Quality Engineer 3

Teleflex; Northern (KY); Hybrid; USD 65,000 - 90,000; Full time

Job summary

Ingenyx is seeking a Quality Engineer 3 to join our manufacturing QA team in Kentucky. You will lead CAPA/NC activities, investigate customer complaints, guide process validations, and support audits. Strong knowledge of QSR, CFR, cGMP, ISO and root-cause tools is essential.

Manufacturing experience and ASQ QA Auditor preferred; BS degree required or equivalent certification. The role emphasizes collaboration, problem solving, and adherence to quality systems to drive compliant product quality

Qualifications

• Bachelor’s degree preferred or ASQ Certified Quality Engineer.
• 3+ years of Quality Assurance experience required.
• Manufacturing experience required; regulated or medical industry experience preferred.

Responsibilities

• Nonconformance (NC) and CAPA coordination and processing.
• Customer complaint investigations.
• Process validations – guide and review protocols and final reports.
• Customer change-notification evaluations.
• Internal and external audit support.
• Quality improvement initiatives.
• Compliance with Ingenyx and local procedures and policies.
• Training and other QA duties as assigned by QA Manager.

Skills

QA knowledge

CAPA NC

Root Cause Analysis

DOE SPC

Minitab

SAP ERP

MS Office

Auditor cert

Design Control

Statistical methods

Education

Bachelor's degree preferred

ASQ Certified Quality Engineer

Tools

Minitab

SAP ERP

Excel

DOE tools

Job description

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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.

The Quality Engineer 3 provides Quality Engineering leadership and support to manufacturing as a lead Quality team member. Key areas of responsibility include:

• 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

• Nonconformance (NC) & CAPA – Lead Quality activities for Conductor Material Review Board coordination, inspection methods, NC containment/correction/closure, and CAPAs. Analyze trend data and drive improvements.
• Customer Complaint Investigations – Lead Conductor complaint investigations, confirmation, and corrective actions. Serve as the primary customer contact for complaint communications and drive improvements based on trends.
• Process Validations – Guide and review protocol development, validation execution, and final reports for acceptance.
• Quality & Cost Improvement – Lead and participate in short‑term product and process improvement projects.
• Production & Process Controls – Review, revise, and approve Manufacturing Procedures, Test Method validations, Quality Inspection Plans, and process run sheets.
• Auditing – Perform internal and process audits; participate in vendor audits as needed; and support Back Room activities during FDA and Notified Body audits.
• Documentation Control – Review Customer Product Specifications. Initiate Engineering Change Notices and review/approve changes as needed.
• Training – Conduct QA training certifications for new Production operators.
• Engineering Support – Support product improvements through quality planning, risk evaluation, and validation.
• Other Duties – Perform additional QA responsibilities as assigned by the QA Manager.

Education / Experience 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 the following areas:

• CAPA and Nonconformance processes
• Customer complaint investigations
• Validation concepts and techniques (process, equipment, and test methods)
• Continuous improvement and project management
• Process and/or internal auditing

Specialized Skills / Other Requirements

• Knowledge of QSR, CFR, cGMP, and ISO regulations required.
• Proficiency with Microsoft Word, Excel, and PowerPoint required.
• Experience with Minitab and SAP ERP preferred.
• Knowledge of statistical techniques preferred (DOE, SPC, Gage R&R).
• 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.
• ASQ Certified Quality Auditor highly preferred.
• Design Control and Risk Management experience preferred.

#LI-DR1

At Ingenyx, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up‑front.

Ingenyx is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or [e-mail].