We are looking for an experienced Senior Quality Engineer with a strong background in medical device quality engineering, regulatory compliance, and dimensional inspection/metrology.
The candidate will support Cerenovus neurovascular medical devices throughout product development, design changes, manufacturing transfer, and sustaining activities. The role involves quality management, design control, risk management, validation, audits, CAPA, and dimensional inspection using advanced metrology equipment.
The ideal candidate should have experience with FDA quality requirements, ISO 13485, GMP, and medical device regulatory standards, along with hands-on knowledge of GD&T, engineering drawings, and inspection equipment.
- 5+ years of quality engineering experience in medical devices or regulated life sciences.
- Knowledge of Quality Management Systems (QMS), GMP, FDA quality requirements, and ISO 13485.
- Understanding of medical device design controls and risk management.
- Hands-on experience with CAPA, nonconformance, deviations, root cause analysis, and change control.
- Experience with DFMEA, PFMEA, risk management records, and technical documentation.
- Experience with verification and validation (V&V), process validation, and IQ/OQ/PQ.
- Knowledge of engineering drawings, tolerances, and GD&T.
- Experience with dimensional inspection and metrology equipment.
- Strong documentation, communication, problem-solving, and project management skills.
- Neurovascular, catheter-based, implantable, or Class II/Class III medical device experience.
- Experience with Windchill or other PLM/eQMS platforms.
- Experience with OGP SmartScope and optical measurement systems.
- Experience with white light scanners, digital microscopes, optical comparators, and hand gauges.
- Experience with technical transfer and manufacturing transfer.
- Knowledge of ISO 14971 and post-market surveillance.
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Manufacturing Engineering, or a related field.
- Provide quality engineering support for medical device product development and manufacturing activities.
- Prepare, review, and maintain Quality Plans, protocols, reports, specifications, and engineering documentation.
- Review and approve verification and validation (V&V) protocols and reports.
- Develop and maintain risk management documentation, including DFMEA and PFMEA.
- Support process validation and equipment qualification activities, including IQ, OQ, and PQ.
- Manage nonconformances, deviations, CAPA, root cause investigations, and audit activities.
- Review Change Orders and assess product, process, quality, and regulatory impact.
- Apply statistical methods for process capability, sampling, and measurement system analysis.
- Support post-market surveillance, complaint trending, and quality improvements.
- Prepare and maintain SOPs, Work Instructions, and QMS documentation.
- Support technical transfer and manufacturing transfer activities.
- Perform dimensional inspections of medical devices and components using contact and non-contact metrology equipment.
- Read and interpret engineering drawings, blueprints, and GD&T specifications.
- Develop and execute inspection programs using OGP SmartScope systems.
- Collect and analyze dimensional data using optical comparators, digital microscopes, white light scanners, and hand gauges.
- Collaborate with engineering teams to determine appropriate measurement and inspection techniques.