Supplier Quality Assurance Specialist
hace 1 mes
CooperCompanies is a leading healthcare company dedicated to delivering innovative solutions that enhance the work of healthcare professionals. We are seeking a highly skilled Supplier Quality Engineer to join our team.
Job Summary:The Supplier Quality Engineer will be responsible for ensuring that our suppliers meet the highest quality standards. This includes conducting audits, verifying compliance with regulatory requirements, and implementing corrective actions as needed.
Key Responsibilities:- Conduct supplier audits and site visits to identify systemic gaps in performance expectations
- Verify supplier compliance with regulatory requirements, including FDA QSR, ISO 13485, and EUMDR
- Implement corrective actions to prevent re-occurrence of failure modes
- Support supplier validation activities and transfer projects
- Collaborate with Quality Engineers, Inspectors, and Purchasing teams to ensure supplier quality
- Develop and implement supplier quality agreements and manage supplier SCAR/CAPA/NCR
- Provide metrics and reports to management on supplier quality performance
- 5+ years of experience in a regulated quality environment
- Knowledge of FDA QSR, ISO 13485, and EUMDR
- Excellent verbal and written communication skills
- University bachelor's degree in Chemical, Electro-Mechanical, Industrial, Bioprocess Engineering, or related field
- Advanced level of English speaking and writing
- Black Belt certification
- Certified Quality Engineer (CQE) or Certified Reliability Engineer (CRE) certification
- Experience with Change Control Systems and Design Control
- Experience with ERP and QMS systems
CooperCompanies offers a competitive salary and benefits package, as well as opportunities for professional growth and development.
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