Quality Assurance Manager -Implementing ISO 13485

5 years

5 - 7 Lacs

Posted:1 week ago| Platform: GlassDoor logo

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Work Mode

On-site

Job Type

Part Time

Job Description

1).
Qualifications & Experience:
Bachelor’s degree in Engineering, Life Sciences, Quality, or related field. Minimum 3–5 years of experience in Quality Management, preferably in the medical device industry. Proven experience implementing ISO 13485. Certification in ISO 13485 Lead Auditor (preferred). Familiarity with medical device regulatory requirements (FDA, CE, etc.). Skills Required:
Strong knowledge of ISO 13485 and QMS principles. Project management and leadership capabilities. Excellent documentation and communication skills. Problem-solving and analytical thinking. Ability to work cross-functionally with departments like R&D, Manufacturing, and Regulatory Affairs.

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