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regional medical devices auditor.

job details

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    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