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Quality Assurance Manager

3 - 5 years

5 - 7 Lacs

thane

Posted:7 hours ago| Platform: Naukri logo

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Skills Required

iso 13485 project management analytical qms employee engagement internal quality auditor life sciences risk management quality system management quality management

Work Mode

Work from Office

Job Type

Full Time

Job Description


Department

Quality

Location

Thane

Work Experience

Minimum 3 5 years of experience in Quality Management, preferably in the medical device industry.
Key Responsibilities:
  • ISO 13485 Implementation:
  • Lead and manage the implementation of ISO 13485 across all relevant departments.
  • Develop and document QMS processes, procedures, and work instructions.
  • Establish a project plan with milestones and timelines for ISO certification.
  • Quality System Management:
  • Ensure ongoing compliance with ISO 13485 and applicable regulatory requirements (e.g., EU MDR, FDA 21 CFR Part 820 if relevant).
  • Coordinate Management Review meetings and Internal Quality Audits.
  • Lead Corrective and Preventive Action (CAPA) processes.
  • Training Awareness:
  • Train employees on ISO 13485 requirements and QMS procedures.
  • Promote quality awareness and ensure employee engagement in the QMS.
  • Documentation Records Control:
  • Manage and maintain quality documentation including Quality Manual, SOPs, Work Instructions, and Records.
  • Establish document control and record retention systems.
  • Audit Management:
  • Prepare for and coordinate external certification audits.
  • Lead internal audits and support audit readiness at all times.
  • Supplier and Risk Management:
  • Evaluate and monitor suppliers as per ISO 13485 requirements.
  • Support risk management processes (in alignment with ISO 14971).
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 RD, Manufacturing, and Regulatory Affairs.

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