Under the supervision of the Supplier Quality Manager, the Supplier Quality Engineer works closely with other functional areas to both manage and improve MPE supplier quality.
Essential Duties and Responsibilities:
- Executes supplier audits, performance monitoring, and incoming quality controls in compliance with ISO 13485 and quality system requirements.
- Assist purchasing, fabrication, powder coating, and assembly in the disposition of internally rejected parts and/or products.
- Lead supplier nonconformance investigations and corrective actions (SCAR/CAPA), including verification of effectiveness and timely closure.
- Create and manage MPE supplier quality scorecards.
- Conduct audits on MPE suppliers – including both QMS and process audits.
- Execute first article inspections and part production approval process (PPAP) on supplied parts and materials.
- Implement and maintain receiving inspection plans based on risk and change control processes.
- Execute incoming receiving inspection on MPE purchased materials .
- Conduct internal audits per the MPE internal audit schedule.
- Assist in maintaining supplier qualification status and ongoing performance data.
- Manage and assess supplier change notifications for impact to MPE products.
- Engage MPE suppliers on quality improvement projects.
Education
- High school diploma or equivalent
- Bachelors degree in relevant field is preferred
Experience and/or Training
- 15+ years of manufacturing experience, preferable with sheet metal/fabrication, powder coating, and assembly processes preferred
- Experience working with suppliers and customers is preferred
- Six Sigma and ISO quality management system experience is preferred
- Experience using calipers, height gages, Romer Arms, CMM’s, Microview devices, etc.
- FDA Experience desired
- Fast paced environment
Physical and Mental Demands
- Continuous: Hearing, seeing, communication, computer use, comprehension, reasoning, decision-making, analysis, math
- Occasional: Lifting