Supplier Quality Engineer
Location
Bothell, WA
Level
Full-Time
Department
Medical Devices
Type
Salary
Job Description
Posted on:
2025-03-27
Responsibilities
- Oversee supplier approval, monitoring, and part qualification.
- Generate inspection plans and conduct process validations.
- Resolve supplier-caused non-conformances to support manufacturing.
- Lead audits of supplier quality systems to ensure compliance.
- Monitor supplier quality metrics to drive process improvements.
- Utilize project management tools for effective workflow.
- Attend departmental meetings and training sessions to maintain professional competence.
Job Requirements
- Minimum of three years of experience in engineering or supplier quality within the medical device industry.
- Bachelor’s degree in engineering or life science discipline.
- ISO 13485 Lead Auditor certification.
- Strong communication and documentation skills.
- Ability to work effectively with diverse groups.
- Knowledge of 21 CFR 820 and ISO 13485:2016.
- Preferred experience in project management, Six Sigma, and Lean methodologies.
