Medical Devices QMS Assessor(home-based)

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As a Medical Device Auditor, you’ll travel to medical device manufacturers across APAC, particularly in Indonesia. You’ll help these manufacturers to improve their performance by assessing their ISO 13485 quality management system, ensuring patient safety and compliance with regulatory procedures.

Responsibilities

In the first six months of being a Medical Device Auditor you’ll:
• Be given training in ISO 13485 Lead Auditor training, MDSAP (Medical Device Single Audit Programme) and MDR (Medical Device Regulation)
• Initially observe how audits are conducted but then grow to conduct them on an individual basis on site at medical device manufacturers across APAC and remotely from your home office

In a typical week after being fully trained you’ll:
• Conduct an audit on site or remotely
• Write up your reports and liaise with the planning team to manage your audit schedule.
• You’ll also continue your development of MDR and be an advocate for the ISO 13485 APAC Delivery Team.

Requirements

To Thrive In This Career, You Must
• Have above 4 years or more being directly accountable for the design or test or manufacture of different medical devices
• Be degree educated with discipline relevant to Medical Devices e.g. chemistry, physical chemistry, molecular genetics, textiles, material science, biology, biotechnology or similar
• Have at least 2 years’ experience working in an environment with a Quality Management System established
• Be able to speak and write fluently in the English and Indonesian language
• Be resilient and able to meet audit delivery by travelling frequently across the APAC region as required.
• Local hire and work from home.