We are currently looking for a Medical Device Auditor to join our Medical and Health Service team! You will be performing the audit for medical device manufacturers and ensuring that their Quality Management System (QMS) complies with Medical Devices – including the Medical Device Regulation (MDR) / In Vitro Diagnostic Medical Devices Regulation (IVDR) and other QMS certification scheme, where applicable.
We welcome experts from different medical device and IVD industries!
For Example:
New technologies: Software as medical device, artificial intelligence, and cyber security
Well established technologies: orthopaedics, imaging, monitoring, tubing-systems, gloves, etc.
Key Responsibilities:
- Perform onsite audits at manufacturer’s premises by evaluating their Quality Management Systems in accordance with the requirements of the MDR / IVDR, and other QMS certification schemes such as ISO 13485, ISO 9001 and MDSAP
- Assist Sales personnel by providing technical advice to existing and prospective clients
- Deal with clients’ queries relating to certification process including application reviews within acceptable time frames as a project manager
- Take charge of pre and post audit tasks including preparation of audit documentation and audit package submission
Key Requirements:
- Bachelor’s degree in Electrical / Software / Medical Engineering, Biomedical Science, Chemical Engineering, or relevant equivalent Sciences
- Have minimum 4 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.
- Have at least 2 years’ experience in Quality Management Systems environment
- Clear and articulate presentation ability with excellent communication skills
- Travelling will be required within ASEAN, with occasional travel to USA and Europe
- Excellent communication and interpersonal skills to collaborate effectively with manufacturers and other team members. Ability to articulate assessment findings clearly and professionally
- Stay up-to-date with the latest developments, trends, and advancements in the software and medical device industry to provide informed evaluations
- The ability to work independently and as part of a team and work under pressure to meet deadlines and maintain confidentiality.
