L&T Technology Services | Lead Auditor | pune
4 days ago
Location: Baroda/Chennai/Pune/Bangalore/Mysore
Job Description
• Work as a Lead Auditor to drive the Supplier Qualification and Part Qualification Medical devices
• Experienced professional in supplier quality management in medical and manufacturing industry.
• Expertise in handling QMS of Medical industry.¬
• Lead quality audits for suppliers and issue audit reports.
• Strong understanding of regulatory requirements for various medical devices / pharmaceutical products including PCBA, machining/casting, injection molding, mechanical hardware, repair activity etc.
• Complete awareness of end-to-end supplier quality Management include supplier selection, qualification, performance management, ASL Management, change control management, Non-conformance management, CAPA management, paper-based audit management, quality agreement management.
• Experience in handling complex quality problems, troubleshoot quality/compliance issue using experience and creativity to provide solution to a wide range of root cause.
• Well versed in management of documentation and quality issues through various quality management.
Review product records to confirm that Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) requirements are met.
• Project management skill and program progress reporting for multiple part & multiple supplier (suppliers might be globally located).
• Experience in managing global supplier communication management and issue resolution.
Required Qualifications
• Minimum of 5 years of experience in a manufacturing environment in medical or related regulated industries.
• Minimum of 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.
• Support programs/projects/forums to identification opportunities, interdependencies, and risks, and develop risk mitigation plans where needed.
External Skills And Expertise
ISO13485 Lead Auditor, Supplier Audits, Internal Audit, PPAP, MSA, SPC
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