Quality System Engineer

Key Responsibilities

• Support implementation of internal quality system requirements and external regulatory standards (e.g., FDA, ISO 13485, cGMP, EU MDR)
• Drive improvements to procedures and standards to enhance efficiency while maintaining compliance
• Support and coordinate CAPA and compliance programs, including facilitating CAPA activities across functions
• Participate in CAPA management activities and global quality system discussions
• Conduct internal audits to identify gaps, ensure compliance, and drive continuous improvement
• Support audit readiness, including front‑room and back‑room activities during external audits and inspections
• Deliver quality system training and guidance to employees across the site
• Lead or participate in system and process improvement initiatives using structured problem‑solving approaches
• Identify areas of non‑compliance and recommend corrective actions to...