Senior Quality System Engineer (PAL)
Core
Ensuring compliance with FDA, ISO, cGMP, and MDR regulations through internal/external audits, CAPA management, and batch release analytical QA support for medical devices.
Role type
Senior Quality System Engineer (Medical Devices)
Builds
Quality system policies, audit schedules, CAPA systems, and compliance reports
Domain
Medical Devices / Regulatory Compliance
Required skills
Internal audit management, External audit management, CAPA systems, Regulatory compliance (FDA, ISO, cGMP, MDR), Quality metrics analysis, Batch release QA support, Laboratory investigation, Management review reporting
Preferred skills
Lead Auditor qualification, Medical device industry experience, Non-conforming events management
Technologies
ISO 13485, EU MDR, FDA Regulations, cGMP, Combination Device Regulations
Responsibilities
Plan and conduct scheduled internal audits to assess compliance with FDA, ISO, cGMP, and MDR; Lead and support site external inspections; Manage and conduct CAPA processes and develop metrics; Provide QA support and direction for analytical laboratory batch release and testing; Educate functional areas on quality system requirements; Collect and analyze business/quality system process data.
Seniority
Senior, hands-on IC