Incoming Supplier Quality Leader

About the role

The Senior Supplier Quality Leader oversees the Supplier Quality Management process for the DR site, supervising the incoming inspection team and ensuring compliance with QMS, FDA, and ISO standards. The role also supports Quality Engineering, process, and validation activities.

Key responsibilities

• Maintain Supplier Quality Management and control all incoming activities.
• Supervise Incoming Quality Inspectors and ensure inspections follow QMS procedures.
• Implement and monitor action plans from supplier and incoming audits.
• Analyze metrics, apply statistical methods, and drive continuous improvement.
• Investigate and document non‑conformities in supplier and incoming processes.
• Validate quality equipment and develop new problem‑solving approaches.
• Support compliance with FDA 21CFR820, ISO 13485, and other regulatory standards.

Required profile

• Bachelor’s degree in an engineering discipline or equivalent.
• Minimum 5 years of quality control experience in a regulated industry.
• At least 5 years supervising receiving and work‑in‑process staff.
• Familiarity with FDA 21CFR820, ISO 13485:2016, and cleanroom requirements.

Required skills

• Microsoft Office suite
• Document control and Quality Management System software
• Inventory and warehouse management software
• Cleanroom testing methodologies
• ISO 13485 and ISO 9001 standards
• FDA 21CFR820 regulatory knowledge
• Lean Six Sigma tools
• Statistical analysis methods for quality evaluation
• Auditing to ISO requirements