Supplier Quality Engineer

We are seeking a Supplier Quality Engineer to support supplier quality management activities, including supplier qualification, process validation, and risk assessment. The ideal candidate will work closely with suppliers and internal teams to ensure compliance with quality standards and timely resolution of quality issues.

• Manage and support Supplier Quality Agreements and evaluate supplier capabilities to identify potential risks.
• Develop, draft, communicate, and own Process Verification and Validation (PV/PV) plans and reports.
• Review supplier special process validations and identify gaps or compliance issues.
• Coordinate with suppliers to close open quality actions and ensure timely completion.
• Investigate and resolve supplier nonconformance's and quality issues.
• Hold suppliers accountable for deliverables, corrective actions, and status updates.
• Collaborate with cross-functional teams to support continuous quality improvement initiatives.

• Bachelor’s degree in Engineering, Quality, or a related technical field.
• Experience in Supplier Quality, Quality Engineering, or Manufacturing Quality.
• Strong knowledge of process validation, supplier audits, and quality systems.
• Familiarity with ISO, FDA, or regulated industry quality standards (preferred).

• Experience working with medical device or regulated manufacturing suppliers.
• Knowledge of corrective and preventive action (CAPA) processes.
• Experience using quality management systems (QMS).