Senior Design Quality Engineer
200 Minuteman Road Suite 302 Andover, MA 01810
Fast-paced environment for a growth minded quality engineer - work with groundbreaking technology!
- Support new product development teams as core quality team member; provide input on customer needs, product requirements, participate in design reviews, etc.
- Lead and facilitate design verification & validation activities; author and/or execute design verification protocols and reports
- Generate Quality plans for new products and work with R&D engineering to develop quality inspection plans for new components and sub assemblies.
- 8+ Years experience in Quality Engineering in the medical device industry with a minimum of 4 years in design & development
- Working knowledge and practical application of Design Controls and experience with 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62366, IEC 62304, and IEC 60601-1
- Experience writing and/or executing verification and validation protocols