I am working with a Medical Device company who is looking for a Quality Engineering Manager to lead product quality from NPD to Post Market. This will have a huge focus on electromechanical products.
- Oversee Quality Engineering support throughout all phases of the product development life cycle including quality support for R&D and NPI, and the way through manufacturing activities
- requirement development, specification development, verification and validation testing, design transfer, risk assessment, usability, design change control
- Risk Management processes, updating risk files. Participate and contribute to the development of product design history file and ensure compliance to internal processes and external standards and regulation
- Have ownership of products adhering to IEC 60601 and IEC 62304.
- Design Transfers
- Lead a team of Quality Engineers
Requirements
- 4+ years of experience working with electro-mechanical medical devices, Software as a Medical Device, and Electrical devices. robotics, or medical software is highly desired
- Experience in Quality, Manufacturing, or Research and Development experience in a medical device industry
- Strong knowledge of FDA requirements for design control of medical devices and 21 CFR 820, ISO 13485, 14971; IEC 60601-1, IEC 62304 medical device software, cybersecurity, and related regulations
