The Supplier Quality Engineer is responsible for driving exceptional product quality for the patient, customer value beyond expectations, regulatory assurance and optimized Cost of Quality for Client.
- Improve supplier quality performance for assigned suppliers via Part Quality Plan (PQP) implementation. Communicate, clarify and facilitate supplier Part Quality Plan (PQP) submissions, as well as conduct PQP review and approval for purchased products.
- Approve supplier selection through robust qualification processes, including supplier audits.
- Assure supplier compliance to client Quality Management System (QMS) and regulatory requirements.
- Assure Corrective and Preventive Action (CAPA) plans are developed and executed at assigned suppliers in compliance with CAPA process.
- Bachelor's Degree in an engineering or technical discipline (or non-technical degree with 5 years of experience in manufacturing, engineering or quality assurance.
- Minimum 3 years' experience in manufacturing, engineering design, quality assurance or regulatory assurance.
- Effective problem solving, root cause analytical skills to lead and influence others to drive change.
- ASQ Certified Quality Engineer or CQA Certified Quality Auditor
- Demonstrated knowledge of Quality Management System tools and continuous improvement methodologies.
- Demonstrated supply quality experience within the medical device industry.