Senior Quality Engineer

About the role

Medical Devices

Tasks

• Support medical device product development, design changes, manufacturing transfers, and sustaining quality activities.
• Support design controls, product development documentation, and verification & validation (V&V).
• Develop and maintain DFMEA, PFMEA, and risk management documentation.
• Lead or support CAPA, nonconformances, deviations, root cause analysis, and change control.
• Support process validation and equipment qualification (IQ/OQ/PQ).
• Maintain QMS documentation, SOPs, quality plans, and audit records.
• Apply statistical methods and support manufacturing and technical transfers.

Requirements

• Strong experience in medical device quality systems, FDA requirements, ISO 13485, risk management, and quality engineering.
• Medical Device Quality Engineering and QMS
• FDA Quality System Requirements, GMP, ISO 13485
• Design Controls, DFMEA, PFMEA, and Risk Management
• CAPA, RCA, Nonconformance, and Change Control
• Verification & Validation and IQ/OQ/PQ
• GD&T, Engineering Drawings, and Process Validation
• PLM/eQMS tools; Windchill is a plus
• Experience with neurovascular, catheter-based, or Class II/III medical devices is highly desirable.

Schedule

• Contract
• Onsite

How to apply

• Send your updated resume by email.

Location

• Cincinnati, Ohio