job details
about the company
Our client is a global leader in providing certification, inspection, and test services for companies across sectors. With an extensive network across ASEAN, this company now has exciting opportunities for a driven Medical/MHS Auditor to join their dynamic team, to support the ASEAN region in performing Audits, inspections and trainings for clients.
about the job
- Perform Audits/Inspections in ISO 13485 / MDD, J-QMS, CMDCAS, MDSAP / Specific medical device standards
- Perform in-house and public training for clients (e.g. ISO 13485 / MDD / Specific Medical Device Standards / QSR)
- Conduct audits on clients’ medical device quality systems based on regulatory requirements for access into EU, Japan and Canada
- Assist Sales by providing technical advice to clients and respond to enquiries
- Process clients’ queries, Change Notifications, EC certificate extensions and audits effectively
- Take charge of pre/post audit tasks including calculation of audit duration, quotations, audit registration, preparation of documentations etc.
- Maintain authorizations for auditing and technical reviews and corresponding objective evidence
- Develop and review audit methodologies for accreditation compliance
- Undergo relevant training, qualification, or certification process to be qualified to provide further services.
- To generate, compile and prepare assessment reports and recommendations for review of certification bodies.
job requirement
- Degree/diploma
- Minimum 5 years of relevant experience in the medical/pharmaceutical/biotechnology industry, with preferably at least 2 years in Quality Assurance work with manufacturers of medical devices
- Good knowledge of medical device directives, ISO 9001 and ISO 13485 standards will be an added advantage
- Global Regulatory Affairs background, including MDD/IVDD is preferred
- Must be comfortable with extensive traveling (up to 50%) within ASEAN (largely Thailand and Malaysia, occasional travel to USA and Europe)
If you are interested in the position, kindly send your CVs to yiling.tan(@)randstad.com.sg.
Please include your availability, expected salary and reason for leaving your current job.
We regret that only shortlisted candidates will be contacted.
Applicants must be fully vaccinated or have a valid exemption in accordance with MOM’s regulations to allow them to enter the workplace. Applicants may be required to share verifiable COVID-19 vaccination documents or proof of a valid exemption at the point of offer. Randstad Pte. Limited and/or the Client reserves the right to withdraw an offer if the applicant fails to provide verifiable COVID-19 vaccination and/or proof of exemption documents.
EA: 94C3609 / Reg: R21103172
about the company
Our client is a global leader in providing certification, inspection, and test services for companies across sectors. With an extensive network across ASEAN, this company now has exciting opportunities for a driven Medical/MHS Auditor to join their dynamic team, to support the ASEAN region in performing Audits, inspections and trainings for clients.
about the job
- Perform Audits/Inspections in ISO 13485 / MDD, J-QMS, CMDCAS, MDSAP / Specific medical device standards
- Perform in-house and public training for clients (e.g. ISO 13485 / MDD / Specific Medical Device Standards / QSR)
- Conduct audits on clients’ medical device quality systems based on regulatory requirements for access into EU, Japan and Canada
- Assist Sales by providing technical advice to clients and respond to enquiries
- Process clients’ queries, Change Notifications, EC certificate extensions and audits effectively
- Take charge of pre/post audit tasks including calculation of audit duration, quotations, audit registration, preparation of documentations etc.
- Maintain authorizations for auditing and technical reviews and corresponding objective evidence
- Develop and review audit methodologies for accreditation compliance
- Undergo relevant training, qualification, or certification process to be qualified to provide further services.
- To generate, compile and prepare assessment reports and recommendations for review of certification bodies.
job requirement
- Degree/diploma
- Minimum 5 years of relevant experience in the medical/pharmaceutical/biotechnology industry, with preferably at least 2 years in Quality Assurance work with manufacturers of medical devices
- Good knowledge of medical device directives, ISO 9001 and ISO 13485 standards will be an added advantage
- Global Regulatory Affairs background, including MDD/IVDD is preferred
- Must be comfortable with extensive traveling (up to 50%) within ASEAN (largely Thailand and Malaysia, occasional travel to USA and Europe)
If you are interested in the position, kindly send your CVs to yiling.tan(@)randstad.com.sg.
Please include your availability, expected salary and reason for leaving your current job.
We regret that only shortlisted candidates will be contacted.
Applicants must be fully vaccinated or have a valid exemption in accordance with MOM’s regulations to allow them to enter the workplace. Applicants may be required to share verifiable COVID-19 vaccination documents or proof of a valid exemption at the point of offer. Randstad Pte. Limited and/or the Client reserves the right to withdraw an offer if the applicant fails to provide verifiable COVID-19 vaccination and/or proof of exemption documents.
EA: 94C3609 / Reg: R21103172