Medical Device Auditor Lead

6 days ago


Bengaluru, Karnataka, India UL Solutions Full time

Job Overview

This position is part of the UL Medical Regulatory Team and involves working with highly regulated Medical Devices.

As an Auditor/Lead Auditor, you will independently assist and support processing of manufacturer submissions to various regulatory programs, including ISO13485, MDSAP, UKCA Medical Device Regulation 2002, CE Medical Device Regulation 2017/745, and InMetro.

Responsibilities:

  • Support contract review/agenda setting for quality management system audits
  • Regularly conduct quality system and technical audits, including CE and UKCA unannounced audits
  • Timely preparation of audit reports and customer Corrective and Preventive Action analysis and responses
  • Subject to training and qualification milestones, perform key Quality Management System audit activities to ensure safe products reach the market
  • Participate in development of UL requirements and assessment methods
  • Provide guidance and support to customers as required, participating in client training and forums
  • National/international travel (50% to 75%) is necessary

Requirements

The ideal candidate should possess a Bachelor's degree, preferably in a field like Pharmacy, Engineering, Technology, or similar. At least four years' professional experience in healthcare products or related fields are required, with two years in quality management. Strong knowledge of manufacturing methods for Medical Devices and legislation relevant harmonized standards are essential.

Compensation

We offer a competitive salary between $90,000 to $110,000 annually, depending on experience and qualifications. The exact compensation can be discussed during the hiring process.



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