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Design Quality Engineer
JOB LOCATION :
South Borough, MA
JOB DUTIES :
- Acts independently with minimal supervision to execute engineering projects specifically targeting to solve engineering problems related to design practices
- Responsible for ensuring that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulations and EU MDR requirements.
- Conduct risk analysis in accordance with Olympus procedures and ISO 14971:2012
- Contribute to the continuous improvement of Olympus risk analysis procedures and product risk
- assessments.
- Responsible for reviewing new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
- Participate on cross-functional teams to develop and maintain Product Risk Management Files (Risk Management Plan, Risk Assessments, DFMEA, PFMEA, Risk Management Report and Performance Evaluation Report Statement) and facilitate Post Launch Risk Management Reviews.
- Work on cross functional teams to support remediation of medical device Design History Files and Technical Files. This includes supporting design control activities such as design inputs, design outputs, design verification and validation, design reviews and other documentation per 21 CFR Part 820.
- Ensure Complaint codes are accurate per the associated information within Risk Management File.
- Support R&D and different Manufacturing sites in developing Process FMEA’s and Design FMEA’s.
- Participate in the development of Design Verification and Validation test plans / protocols and provide guidance on Product Requirements compliance.
- Participate in engineering Design Reviews.
- Provide guidance and direction for sample size and statistical analysis of Verification and Validation testing.
- Provide training to project teams on all Quality Policies / Procedures (including verification, validation, statistical methods and design controls), when necessary.
- Provide Quality support to facilitate the rapid resolution of Product Complaints and/or Patient Safety issues.
- Utilize design life cycle tool for updating/creating product design documentation.
- Perform other design quality engineering tasks as assigned to ensure the quality documents are aligned to ISO 13485.
Education Required :
A Minimum of Bachelors in Mechanical Engineering or related field