Quality Engineer (Medical Device)

Overview

Quality Oversight: Ensure manufacturing processes meet internal standards, regulatory requirements, and customer expectations.

Responsibilities

• Validation Support: Participate in or review process validation, ensuring proper controls, documentation, and data integrity.
• Problem Investigation & RCA: Lead or support root cause analysis of quality issues, implement corrective and preventive actions (CAPA).
• Compliance & Documentation: Maintain and approve quality documentation, including control plans, inspection procedures, validation documents.
• Continuous Improvement Support: Collaborate with manufacturing to ensure process improvements do not compromise product quality.
• Supplier & Component Quality (if applicable): Support other team members to evaluate supplier performance.
• Supports post-market surveillance (PMS): by investigating complaints, identifying trends, and using the findings to drive proc...