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Design Quality Engineer
- Posted: 09/04/2024
- Salary: Competitive
- Location: Boston, Massachusetts, United States
- Job Type: Permanent/Fixed Term
Opportunity to join a leader in medical laboratory equipment focused on new product development. As part of their Quality team, this role will be covering design controls, design assurance, writing requirements, and design traceability within a company that are steadily growing out their operations and QARA team.
Main Responsibilities:
Main Responsibilities:
- Assure new products exceed customer expectations and meet applicable standards by applying expert knowledge of quality principles and tools.
- Supporting project team activities toward meeting NPD deliverables including requirements management, design reviews, design verification, design validation, design transfer to manufacturing, documentation completion tracking, and product release authorization for distribution of product.
- 3 years’ experience in Design Quality within the Medical Devices industry.
- In depth knowledge of ISO 9001 or similar. Familiarity with ISO 13485, IVDD 98/79/EC, MDD 93/42/EEC preferred.