Supplier Quality Engineer (OH)
Medical Engineering Consultants (MEC) · Ohio, United States · 2 days ago
Quality AssuranceFull-time
Responsibilities
- Qualify and maintain suppliers, including audits and ongoing performance monitoring
- Support New Product Introduction (NPI) activities, including supplier validation and approval (PPAP/APQP or equivalent)
- Review and approve supplier documentation (control plans, PFMEA, process validations)
- Monitor supplier quality metrics and drive improvement actions
- Lead supplier nonconformance investigations and manage SCAR/CAPA
- Support complaint investigations related to supplier components
- Maintain supplier records, including Approved Supplier List (ASL)
- Support internal and external audits
Requirements
- Bachelor's degree in Engineering or related field
- 4+ years Supplier Quality experience in medical device or regulated industry
- Experience with: PPAP/APQP or structured supplier qualification processes, CAPA, root cause analysis, Risk tools (PFMEA)
- Knowledge of ISO 13485, FDA QSR and EU MDR
Qualifications
BS in Engineering or related field
Skills
Supplier Quality experience in medical device or regulated industry
Experience with: PPAP/APQP or structured supplier qualification processes, CAPA, root cause analysis, Risk tools (PFMEA)
Knowledge of ISO 13485, FDA QSR and EU MDR
Benefits
N/A
Pay
N/A
Schedule
N/A
Benefits
N/A