Senior, Manufacturing Quality Engineer
About The Position
The Senior Manufacturing Quality Engineer leads process risk management for manufacturing transfer and daily production demand, and identifies and supports continuous improvement opportunities. The role applies quality engineering practices across manufacturing processes and commercialized products, including risk management, validation, inspection planning, failure investigation, and process improvement. It works closely with engineering, logistics, finance, and program management disciplines to define system specifications and requirements, while supporting compliance and customer-focused interactions. The position is onsite in an office and manufacturing environment in Bothell, Washington. Employees typically work at a computer, with periods of standing, walking, bending, and carrying papers and books. The role requires normal visual acuity and hearing, and the ability to sit and use hands and fingers to operate a keyboard.
Requirements
- At least 7 years of experience, or equivalent experience, in medical device manufacturing.
- Experience applying ISO 14971, 21 CFR 820, ISO 13485, IEC 62304, and IEC 60601.
- Bachelor’s degree in an engineering or life science discipline.
- Experience with manufacturing transfer, process validation, and sustaining mechanical and software-driven devices.
- Experience creating and maintaining process risk management.
- Experience developing test methods and validating those methods.
- Experience developing and implementing inspection plans.
- Strong technical ability using computational tools and electronic QMS.
- Ability to quickly learn new applications, tools, and concepts.
- Strong work ethic and ability to excel in a flexible, fast-paced work environment.
- Ability to provide guidance and mentorship on quality principles and practices.
- Excellent written and oral communication skills.
- Ability to work effectively with diverse groups of people.
Nice To Haves
- Master’s degree in an engineering or life science discipline.
- Six Sigma (DMAIC) experience.
- Lean experience.
Responsibilities
- Lead process risk management for manufacturing transfer and daily production demand.
- Identify and support continuous improvement opportunities.
- Perform metrology, process mapping, pFMEA, control planning, test method validation, validation, process improvements, CAPA, nonconformance, and change management activities.
- Review and approve changes to currently commercialized products with respect to product process risk management.
- Apply statistics to make business decisions.
- Conduct failure investigations and root cause analyses.
- Use critical thought to provide pathways for business continuity and improve systems in lower-maturity processes.
- Coordinate and work closely with engineering, logistics, financial, and program management disciplines to define system specifications and requirements.
- Attend departmental meetings and relevant seminars and training sessions to maintain professional competence.
- Ensure department compliance guidelines are met.
- Attend meetings, in-service training, or continuing education as delegated by the supervisor.
- Provide customer-focused interactions and perform duties required by department policies and procedures.
- Perform other duties and responsibilities delegated by the supervisor within the scope of the role.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
