Baru Medical and Health Services (MHS) Auditor

Date Posted: Posted7 hari yang lalu

Salary:

Jakarta

Tasks

The ideal candidate should have passion for the Medical Device industry with a strong interest in serving clients in and out of Indonesia.
The selected candidate, if s/he has no experience yet in the MHS business, will undergo specific training and authorization to obtain the required qualifications to qualify as a full-fledged Medical Device Auditor. Upon completion of the authorization process, the incumbent will be responsible for conducting audits on Medical Devices in accordance to international standards.
Key Responsibilities:

Conduct audits on medical device quality systems based on ISO 9001, ISO 13485, MDD 93/42/EEC, MDSAP and other regulatory requirements for access into EU, Japan, Canada and US
Ensure timely submission of audit reports
Address technical enquiries and propose quotations for medical device certification related services
Travel overseas as required to interface with clients outside of Indonesia
Participate in mandatory training courses as part of the medical device auditor authorization process
Perform business and service support work as assigned

Qualifications

Bachelor or Postgraduate degree in Electrical and Electronics Engineering, Biomedical Engineering or related discipline
At least 3 years of relevant experience in medical device manufacturing Quality Assurance and/or process validation roles
A proactive, enthusiastic, and resourceful team player with a “can-do” attitude
Conversant in Bahasa and English, both written and spoken
Ability to work independently to assume challenging projects within tight timelines
Training bond applies for the completion of the auditor authorization process