Staff Supplier Quality Engineer

Staff Supplier Quality Engineer position focused on improving material quality from suppliers, managing supplier relationships, and ensuring compliance with quality system regulations and FDA standards. The role involves leading corrective and preventive actions, conducting supplier audits, and driving continuous improvement initiatives across the supply base.

Responsibilities

• Lead corrective and preventive actions to prevent non-conforming supplier materials from entering operations
• Manage and develop key supplier relationships to build capability and meet quality expectations
• Initiate and oversee supplier improvement projects including process analysis and Six Sigma initiatives
• Conduct supplier audits to verify compliance with regulatory requirements and Illumina standards
• Monitor supplier quality metrics and drive timely resolution of quality issues

Requirements

• 8+ years quality assurance experience in regulated environment; IVD manufacturing preferred
• Quality certification preferred, such as Certified Quality Engineer
• Knowledge of 21 CFR 820, ISO 13485, ISO 14971, IVDD, and related regulatory standards
• Practical experience with design controls, risk management, validation, and change control
• Proficiency in CAPA tools, failure investigation techniques, and statistical analysis methods
• Strong communication skills and ability to work independently with minimal supervision
• Ability to travel internationally to supplier locations as needed