Senior Quality Engineer
5900 First Ave S Seattle, WA 98108
Position Title: Senior Quality Engineer
Position Description: Protingent Staffing has an exciting opportunity with our client in Seattle, WA. The Senior Quality Engineer is responsible for overseeing the quality of products from Design Transfer, Production and Post-Production activities.
- Write, review and/or approve product specifications, test protocol/reports, and manufacturing/inspection processes.
- Work with New Product Development to effectively transfer new product designs into the manufacturing process. Assists with the creation of Design Transfer documentation.
- Assist in developing manufacturing processes and optimizing current processes to improve reliability.
- Establish process monitoring goals using appropriate statistical techniques.
- Devise and execute experimental studies, including GD&T, Gage R&R, DOE, etc.
- Provide input into process validation activities, including IQ, OQ and PQ requirements.
- Develop supplier quality plans using risk based assessments to determine inspection requirements and acceptance criteria.
- Participate and/or lead Material Review Boards (MRB) to ensure that non-conforming product is properly investigated and dispositioned.
- Participate in the Risk Management program, including updating risk analyses, participating in Process FMEA’ s, and maintaining Risk Management documents.
- Perform analysis of returned goods, document findings and conduct trend analysis of the results.
- Submit trends for possible Corrective and Preventive Actions.
- Conduct Corrective and Preventive Action activities to investigate causes of non-conformance, determine root cause and implement corrective actions to eliminate quality problems.
- Use relational databases and reporting tools to collate and analyze quality data. Have knowledge of and use statistical data analysis tools (e.g. Minitab).
- Create, implement and teach new quality systems as required
- BS degree in Engineering discipline or equivalent degree + experience
- Minimum of eight years’ experience in engineering related industry, of which 5 years should be in the medical device industry.
- Direct experience with FDA QSR and ISO 13485 compliance.
- Knowledge of development, validation and manufacture of medical devices.
- Experience with electro-mechanical equipment required.
- Experience with 60601, UL and EMC requirements a plus.
About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding and exciting work opportunities for our candidates.