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job details

summary

    job details

    about the company

    Our client is a leading manufacturer of innovative contact lenses and services, with main manufacturing sites in Singapore and other affiliates in other global markets. WIth a strong commitment to industry R&D, this company is now looking for a driven QA manager to lead their QA team.

    about the job

    Reporting into the Managing Director directly, you will:

    • Ensure overall compliance adequacy and operational effectiveness of the QA Operations for the contact lens and lens care products manufacturing.
    • Formulate and implement work procedures that meet quality and regulatory requirements.
    • Ensure high level of compliance to ISO 13485, EU MDR 2017/745, MDSAP regulations and other relevant national authorities requirements
    • Support the documentation of CVM GDPMD system to ensure its compliance to MY-MDA requirements.
    • Work closely with internal departments to resolve internal and external quality issues; and to improve overall process yield.
    • Leading and participating in quality improvement programs and cross functional projects.
    • Conduct failure analysis for customer complaint returns & manage customers’ complaint
    • Coordinate with supplier(s) on the quality trends, including the corrective and preventive actions through Supplier Management Program.
    • Develop, implement, monitor and maintain ISO 13485 QMS Certification, MDSAP Certification, CE Certification, MOH Certification and other GMP systems.
    • Update and maintain the National and International Regulations Requirements Guidance, Standards and Technical Guides & ensure that gap analysis is performed
    • Act as QMR and PRRC with scope as stated in the Quality Manual and liaise with third party auditors (NB and Regulatory authorities) or inspectors in relation to site audits, desk audits or random inspections.

    job requirement

    • Degree in Engineering, Life Sciences or equivalent.
    • ISO 13485:2016 lead auditor
    • Minimum 3 years of quality management related experience in the medical device/biotechnology/pharmaceutical industry with minimum 2 years experience in regulatory affairs.
    • Familiar with cGMP and EU MDR 2017/745 requirements.
    • Working knowledge of metrology tools and equipment such as calipers, micrometers and lensmeter.
    • Knowledgeable in Validation/Qualification process..
    • Proficient in Minitab and MS Office applications.

    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 leading manufacturer of innovative contact lenses and services, with main manufacturing sites in Singapore and other affiliates in other global markets. WIth a strong commitment to industry R&D, this company is now looking for a driven QA manager to lead their QA team.

    about the job

    Reporting into the Managing Director directly, you will:

    • Ensure overall compliance adequacy and operational effectiveness of the QA Operations for the contact lens and lens care products manufacturing.
    • Formulate and implement work procedures that meet quality and regulatory requirements.
    • Ensure high level of compliance to ISO 13485, EU MDR 2017/745, MDSAP regulations and other relevant national authorities requirements
    • Support the documentation of CVM GDPMD system to ensure its compliance to MY-MDA requirements.
    • Work closely with internal departments to resolve internal and external quality issues; and to improve overall process yield.
    • Leading and participating in quality improvement programs and cross functional projects.
    • Conduct failure analysis for customer complaint returns & manage customers’ complaint
    • Coordinate with supplier(s) on the quality trends, including the corrective and preventive actions through Supplier Management Program.
    • Develop, implement, monitor and maintain ISO 13485 QMS Certification, MDSAP Certification, CE Certification, MOH Certification and other GMP systems.
    • Update and maintain the National and International Regulations Requirements Guidance, Standards and Technical Guides & ensure that gap analysis is performed
    • Act as QMR and PRRC with scope as stated in the Quality Manual and liaise with third party auditors (NB and Regulatory authorities) or inspectors in relation to site audits, desk audits or random inspections.

    job requirement

    • Degree in Engineering, Life Sciences or equivalent.
    • ISO 13485:2016 lead auditor
    • Minimum 3 years of quality management related experience in the medical device/biotechnology/pharmaceutical industry with minimum 2 years experience in regulatory affairs.
    • Familiar with cGMP and EU MDR 2017/745 requirements.
    • Working knowledge of metrology tools and equipment such as calipers, micrometers and lensmeter.
    • Knowledgeable in Validation/Qualification process..
    • Proficient in Minitab and MS Office applications.

    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