INGENYX - Quality Engineer 3

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

• ◆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

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.

• ✓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

• ✓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.

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.