Senior Quality System Engineer

Responsibilities

• Ensure compliance with internal quality systems and external regulatory requirements (e.g., FDA, ISO 13485, cGMP, EU MDR and other applicable standards)
• Lead and support external inspections and regulatory audits
• Plan, coordinate, and conduct internal audits, including identifying gaps, investigating findings, and driving corrective actions
• Identify areas of non-compliance and drive continuous improvement initiatives
• Act as subject matter expert (SME) for CAPA processes, ensuring effective implementation and timely closure
• Maintain and continuously improve site CAPA processes and systems
• Develop, track, and report CAPA metrics to support management review activities
• Support corrective and preventive action processes across the site
• Collaborate cross-functionally to standardize quality system policies and procedures
• Provide training and guidance to teams on qu...