INGENYX - Quality Engineer 3

Position Summary

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

Principal Responsibilities

•    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.

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