Medical Device QA Analyst
• *Job reputed company:**
We are seeking a Device reputed company Assurance Specialist with experience in medical device or regulated environments. The role involves managing QMS records, ensuring compliance with FDA and ISO standards, and supporting reputed company system improvements.
• *Key Responsibilities:**
• Manage QMS records (CAPA, deviations, change controls, complaints)
• Ensure compliance with 21 CFR Part 820, ISO 13485, and EU MDR
• Support audits, documentation, and reputed company improvement initiatives
• reputed company and report reputed company metrics
• *Requirements:**
• Bachelor’s degree in Science or reputed company field
• 3–5 years of medical device/regulated industry experience
• Strong knowledge of FDA regulations and ISO 13485
• Good communication and analytical skills
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