Overview
Design Quality Engineer Jobs in Somerville, USA at Vir Healthway
Required experience:
- Experience in Medical devices
- Strong Knowledge in verification and validation
- Writing test protocol/Reports for Mechanical and Usability lab testing.
- Experience in Product transfer projects
- Metal and Plastic Manufacturing process & Techniques
- Strong Knowledge in DCRM/sales & complaint data/risk management reports/technical
- documents related to design and manufacturing
- Exp. in Risk management Process (ISO 14971)
- Exp. in Design control documentation
- Strong Knowledge in regulatory documents
- Design change evaluation checklists for all labeling documents
- Strong Knowledge in other standard Design Quality activities related to design transfer and manufacturing processes
- Experience ISO 13485 standard and FDA and MDD / MDR Requirements
Essential:
- Process excellence / QE tools such as pFMEA , SE , statistical analysis , SPC
- CAPA experience
- PLM & MS Excel
Title: Design Quality Engineer
Company: Vir Healthway
Location: Somerville, USA
Category:
