Supplier Quality Engineer
On-siteConcord, North Carolina, United States
Job Summary
Perform incoming raw material inspections, approve material releases, and maintain purchasing specifications and process documentation. Partner with Production, Material Control, Engineering, and cross-functional teams to ensure supplier quality and management requirements are met. Serve as a quality and regulatory resource for plant operations, project teams, and external stakeholders. Investigate and resolve incoming material quality issues while coordinating the disposition of nonconforming materials. Conduct supplier audits, support assessments, and manage supplier quality activities for both internal and external suppliers. Lead continuous improvement initiatives using established quality methodologies and monitor supplier quality performance metrics. Collaborate with Engineering to establish process parameters and acceptance criteria, and maintain accurate supplier documentation including Approved Supplier Lists. Support regulatory, customer, and internal audits while ensuring compliance with all safety regulations and BD quality standards.
Required Qualifications
- B.S. or B.A. Degree in Science-related field, Quality Assurance, Engineering, Mathematics/Statistics or equivalent degree
- 1 year of supplier quality experience
- Minimum of 4 days of in-office presence per week
- Proof that you are fully vaccinated against COVID-19
Desired Qualifications
- Certified Quality Auditor
- Prior auditing experience
- Prior experience with ISO 13485:2016 and or applicable laws
- Prior experience working in the Medical Device field
- Working knowledge of Validations, IQ, OQ, PQ, and DOE's
- Consistent record of supporting and driving continuous improvement activities in a production environment
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