This is an on-site position in Andover, MA.
At this time, this client is not able to sponsor/transfer visas.
A growing Class II/III Medical device organization is looking to add a Senior Design Quality Engineer to their team. This individual will be responsible for managing the design control process and assisting with both NPI and Sustaining projects.
Key Responsibilities:
- Partner with cross-functional teams to ensure all design control requirements are met.
- Be a subject matter expert on Quality Engineering and Validation
- Approve Change Notices and manage DHF deliverables
Key requirements:
- Bachelor of Science and 8-10 years of related experience in the medical device industry
- Working knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971
- Strong validation and IQ/OQ/PQ experience
- Experience performing statistical analyses
