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Senior Supplier Quality Engineer - Olympus Corporation
Software Engineer
Senior Supplier Quality Engineer driving supplier performance, quality assurance, and continuous improvement for medical device manufacturing using Six Sigma, CAPA, and ISO 9001 standards.
About the role
Key Responsibilities
- Lead supplier qualification, audit, and performance monitoring to ensure compliance with medical device regulations and internal quality standards.
- Develop and implement corrective and preventive action (CAPA) plans, root cause analyses, and risk assessments for supplier‑related quality issues.
- Collaborate with cross‑functional teams (Engineering, Production, Regulatory) to define supplier specifications, design for manufacturability, and quality metrics.
- Utilize statistical process control (SPC) and Six Sigma tools to analyze supplier data, identify trends, and drive continuous improvement initiatives.
- Maintain supplier quality documentation, including audit reports, qualification records, and quality agreements, in accordance with ISO 9001 and regulatory requirements.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, or related field; advanced certification (e.g., Six Sigma Green/Black Belt) preferred.
- 5+ years of experience in supplier quality engineering within the medical device or high‑regulation industry.
- Strong knowledge of ISO 9001, ISO 13485, CAPA processes, and FDA/ISO regulatory frameworks.
- Proficiency in root cause analysis, risk management, and statistical analysis tools (Minitab, JMP).
- Excellent communication, stakeholder management, and problem‑solving skills.