Supplier Quality Engineer
- Investigate reported product problems, complaints and repair activity trends related to supplier quality.
- Collaborate with suppliers to perform root-cause analysis and take appropriate corrective action.
- Manage and track supplier corrective action requests to ensure action is taken in a timely manner.
- Assist in the review and disposition of nonconforming materials.
- Review/audit supplier manufacturing processes and quality systems.
- Work with Engineering & Purchasing to approve new suppliers and qualify parts for production approval.
- Work with Purchasing to analyze supplier change requests and communicate proposed changes to Engineering.
- Provide feedback about supplier quality during regular Supplier Reviews.
- Perform other duties as requested.
- BS in Engineering or equivalent four-year degree.
- 3+ years relevant work experience.
- Proficiency in reading and understanding technical product documentation (diagrams, schematics, flow-charts, etc.)
- Proficient in the use of Microsoft Office tools such as Word, Excel, PowerPoint, Outlook, etc.
- Comfortable with using PC tools and Windows OS, with a working knowledge of local and network based file systems.
- Excellent verbal and written communication skills using the English language.
- Able to coordinate multiple activities and actions of persons contributing to assigned tasks.
- Detail oriented with good organizational and record keeping skills.
- Ability to work independently and as part of a team.
- Proactive and timely in execution of assigned tasks.
- Able to be flexible and adaptable when needs and priorities change.
- Work experience with similar responsibilities at a medical device company.
- Experience with manufacturing / quality methodologies such as QFD, six-sigma, lean, etc.
- ASQ or related quality certification.
- Familiarity with regulatory requirements of medical devices.
- Familiarity with formal quality systems such as ISO 9001 or ISO 13485.
- Understanding of statistical analysis techniques and tools.