The Senior Quality Engineer is responsible for overseeing the quality of Natus Medical products from Design Transfer, Production and Post-Production activities.
1. Write, review and/or approve product specifications, test protocol/reports, and manufacturing/inspection processes.2. Work with New Product Development to effectively transfer new product designs into the manufacturing process. Assists with the creation of Design Transfer documentation.3. Assist in developing manufacturing processes and optimizing current processes to improve reliability. Establish process monitoring goals using appropriate statistical techniques.4. Devise and execute experimental studies, including GD&T, Gage R&R, DOE, etc.5. Provide input into process validation activities, including IQ, OQ and PQ requirements.6. Develop supplier quality plans using risk based assessments to determine inspection requirements and acceptance criteria.7. Participate and/or lead Material Review Boards (MRB) to ensure that non-conforming product is properly investigated and dispositioned.8. Participate in the Risk Management program, including updating risk analyses, participating in Process FMEA’s, and maintaining Risk Management documents.9. Perform analysis of returned goods, document findings and conduct trend analysis of the results. Submit trends for possible Corrective and Preventive Actions.10. Conduct Corrective and Preventive Action activities to investigate causes of non-conformance, determine root cause and implement corrective actions to eliminate quality problems.11. Use relational databases and reporting tools to collate and analyze quality data. Have knowledge of and use statistical data analysis tools (e.g. Minitab).12. Create, implement and teach new quality systems as required.
Minimum Requirements1. BS degree in Engineering discipline or equivalent degree + experience2. Minimum of eight years’ experience in engineering related industry, of which 5 years should be in the medical device industry.3. Direct experience with FDA QSR and ISO 13485 compliance.4. Knowledge of development, validation and manufacture of medical devices.5. Experience with electro-mechanical equipment required. Experience with 60601, UL and EMC requirements a plus.