One of my clients is a growing leader in the Medical Device space recognized for their novel developments in MedTech and innovative technology.
This person will oversee:
- Manage a team across Quality support for Manufacturing, and sustaining complaint handling.
- This person will own and drive compliance for product launches, process validations, audit readiness, manufacturing lines, and promote continuous improvement to manufacturing processes and product quality.
- This person will drive CAPAs, NCRs, Supplier Controls, Audit Support.
- Lead sustaining line support for Class III devices
- Implement process control systems, develop and maintain quality metrics.
Requirements
- 2+ years of experience leading a team in Quality
- 10+ years of Medical Device experience in an ISO 13485 environment with class III devices.
- Experience within a manufacturing environment as the Quality Engineering support
- Comfortable working in a class 8 clean room.
- class II and III Medical Device experience
- ISO 13485
- ASQ CQE
