Lead Quality Engineer – Medical Devices & CAPA

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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.

• 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

• 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…