Medical Lead Auditor

4 weeks ago


Pune, Maharashtra, India L&T Technology Services Full time
Job Description

We are seeking a skilled Medical Lead Auditor to drive supplier qualification and part qualification for medical devices.

This role requires experience in supplier quality management, particularly in the medical and manufacturing industries. The ideal candidate will have expertise in handling QMS of Medical industry, leading quality audits for suppliers, and issuing audit reports.

A strong understanding of regulatory requirements for various medical devices/pharmaceutical products is necessary, including PCBA, machining/casting, injection molding, mechanical hardware, repair activity, etc.

The selected candidate will have complete awareness of end-to-end supplier quality Management, including supplier selection, qualification, performance management, ASL Management, change control management, Non-conformance management, CAPA management, paper-based audit management, quality agreement management.

Responsibilities include managing global supplier communication, resolving issues, and ensuring compliance with Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) requirements.

Required Qualifications:

  • Minimum 5 years of experience in a manufacturing environment in medical or related regulated industries.
  • Minimum 5 years of experience in supplier audits.
  • ISO 13485 Lead auditor is preferred.
  • Expertise in standard requirements of ISO 17025, ISO 27001, or related regulatory requirements preferred.
  • Willingness to travel for performing onsite visits.
  • Good program management and analytical skills.
  • Should have good communication and team Coordination skills.
  • Able to handle customer and supplier communication simultaneously.
  • Excellent communication, negotiation, and presentation skills.

Compensation:

Based on location and experience, the estimated salary range is ₹1200000 - ₹1800000 per annum.

Benefits:

L&T Technology Services offers a comprehensive benefits package, including health insurance, retirement plans, and paid time off.



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