Leading Manufacturing Expert Wanted

2 days ago

Hyderabad, Telangana, India beBeeManufacturing Full time ₹ 18,00,000 - ₹ 25,00,000
Senior Manufacturing Engineer Job Summary

We are seeking an experienced manufacturing professional with 10+ years of hands-on expertise in the medical device industry to support and enhance our operations.

This senior role involves leading the development, optimization, and validation of manufacturing processes for Class II/III medical devices. You will drive process activities, including IQ, OQ, PQ, and Test Method Validation, to ensure compliance with regulatory requirements.

Main Responsibilities:
  • Process Development: Lead the creation of efficient manufacturing processes that meet quality and regulatory standards.
  • Process Validation: Drive IQ, OQ, PQ, and Test Method Validation activities to ensure compliance with FDA, ISO 13485, and GMP regulations.
  • Collaboration: Work closely with R&D, Quality, and Regulatory teams to ensure smooth operation and alignment with company goals.
Requirements:
  • 10+ years of experience in manufacturing engineering, preferably in the medical device industry.
  • Proven track record in process development, validation, scale-up, and continuous improvement.
  • Excellent knowledge of FDA, ISO 13485, and GMP regulations.
Work Arrangement:

Please note that this is a remote position requiring a strong work ethic and self-motivation.

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