Medical Device Auditor

2 days ago

Pasig, National Capital Region, Philippines beBeeAuditor Full time ₱750,000 - ₱1,000,000
Job Overview

Auditing Medical Devices for Compliance

We are seeking a professional to conduct audits of medical device manufacturers and ensure their Quality Management Systems meet the required standards.

This role involves evaluating the QMS of medical device manufacturers in accordance with the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).

  • Audit Expertise:
  • Performing onsite audits at manufacturer's premises
  • Evaluating Quality Management Systems in accordance with MDR, IVDR, and other QMS certification schemes

The ideal candidate will have experience in testing medical devices, design and development activities, process validation, and application of process technology.

Suitable candidates should also possess excellent communication skills, be able to present complex information clearly, and have experience working in a Quality Management Systems environment.

This position requires strong analytical and problem-solving skills, as well as the ability to travel within a specific region.

Requirements
  • Bachelor's degree in Electrical / Biomedical Engineering, Biomedical Science, Pharmaceutical, Chemical Engineering, Chemical Science, Biotechnology or relevant Sciences
  • Minimum 5 years of relevant experience in testing of medical device / design and development activities / process validation / application of process technology / service & maintenance in the medical device industry
  • At least 5 years' experience in Quality Management Systems environment
  • Excellent communication and presentation skills
  • Ability to travel within PH, with occasional travel to ASEAN
Additional Information
  • Seniority level: Mid-Senior level
  • Employment type: Full-time
  • Job function: Consulting
  • Industries: Medical Equipment Manufacturing

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