Location
Danvers, MA | United States
Job description
Role : Design Quality Engineer
Location : Danvers, MA
JD :
- Support Design Quality Engineering activities for medical products involving Electromechanical capital systems.
- Conduct quality reviews and support in medical products Life Cycle processes including design controls, quality planning, risk management assessments, design reviews, test method development and validation, design verification and validation test plans, protocols, and reports.
- Lead, conduct and own risk management activities including Hazard Analysis, System Risk Analysis, and various FMEAs (Design, Use, Process)
- Ensure that Design controls are compliant with all national and international quality and regulatory requirements and standard like FDA, ISO13485, EU MDR, ISO 14971, IEC 62366.
- Review and approve Change Requests and Engineering Change Orders (ECO) as required.
- Work with cross-functional team for initial product launch and significant design changes
- Contribute to the design, development, and implementation of product assurance plans providing feedback to corrective and preventative actions to engineering, manufacturing, service and field operations and supplier performance.
- Knowledge in statistics, sampling plans and perform data analysis.
Job tags
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