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Senior Quality Lead / Senior Engineer / Assistant Manager Quality As Innvolution Healthcare

5.0 - 10.0 years

7 - 10 Lacs

Bengaluru

Work from Office

Role & responsibilities We are looking for a highly skilled and motivated Senior Quality Lead / Senior Engineer / Assistant Manager Quality Assurance to join our dynamic team in Bangalore . Key Responsibilities: Prepare, review, and maintain QMS documentation in line with ISO 13485. Conduct root cause analysis of non-conformances and implement CAPA. Support regulatory and certification audits (ISO 13485, CE, US FDA, etc.). Conduct internal audits and ensure timely closure of findings. Facilitate management review meetings and prepare related documentation. Maintain Design History Files (DHF) and Device Master Records (DMR). Review and validate engineering change requests (ECR/ECN). Lead vali...

Posted 3 months ago

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