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senior/incoming quality engineer (medical).

job details

summary

    job details

    about the company

    Our client is a global manufacturer of medical devices used in interventional, diagnostic and therapeutic procedures. The manufacturing facility here in Singapore focuses on Critical Care product development and R&D and they’re on a look out for a Senior/QA Engineer to join their Quality Assurance team during an exciting time in their development.

    about the job

    Reporting into the Quality Engineering Leader, you will:

    • Provide support in the implementation of IQA & Boxing quality system in accordance with international standards (such as ISO 13485, etc) and Quality System Requirements (QSR) of agencies such as US FDA and other regulatory bodies
    • Lead supplier audit program and participate in internal audit
    • Provide support in root cause investigation and failure analysis on the customer/field complaints and production issues, especially on the assembly & automation process related quality issues.
    • Provide support on product/process qualifications
    • Support key initiatives such as reduction in Lot Rejection Rate, Non-Conformance Report, and inspection turn-around time, etc.
    • Play an active role in the Supplier Management Team.
    • Review non-conformance materials and work orders and make recommendations for their disposition to support the sales fulfillment process
    • Provide support on supplier management programs including qualification and assessment of new suppliers as well as supplier visit.
    • Provide QE support in the finished goods inspection.

    job requirement

    • Diploma/degree in Engineering/Science or quality related field
    • Minimum 3 to 5 years of relevant experience
    • Minimum 3 years of supervisory experience is required to be considered for the senior position
    • Experienced in Supplier Quality Management and Quality Management System.
    • Experience in cGMP, ISO 13485 and FDA QSR 21 CFR 820 quality systems are essential and MDSAP requirements are an added advantage.
    • Knowledge in plastic/polymer technology.

    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 manufacturer of medical devices used in interventional, diagnostic and therapeutic procedures. The manufacturing facility here in Singapore focuses on Critical Care product development and R&D and they’re on a look out for a Senior/QA Engineer to join their Quality Assurance team during an exciting time in their development.

    about the job

    Reporting into the Quality Engineering Leader, you will:

    • Provide support in the implementation of IQA & Boxing quality system in accordance with international standards (such as ISO 13485, etc) and Quality System Requirements (QSR) of agencies such as US FDA and other regulatory bodies
    • Lead supplier audit program and participate in internal audit
    • Provide support in root cause investigation and failure analysis on the customer/field complaints and production issues, especially on the assembly & automation process related quality issues.
    • Provide support on product/process qualifications
    • Support key initiatives such as reduction in Lot Rejection Rate, Non-Conformance Report, and inspection turn-around time, etc.
    • Play an active role in the Supplier Management Team.
    • Review non-conformance materials and work orders and make recommendations for their disposition to support the sales fulfillment process
    • Provide support on supplier management programs including qualification and assessment of new suppliers as well as supplier visit.
    • Provide QE support in the finished goods inspection.

    job requirement

    • Diploma/degree in Engineering/Science or quality related field
    • Minimum 3 to 5 years of relevant experience
    • Minimum 3 years of supervisory experience is required to be considered for the senior position
    • Experienced in Supplier Quality Management and Quality Management System.
    • Experience in cGMP, ISO 13485 and FDA QSR 21 CFR 820 quality systems are essential and MDSAP requirements are an added advantage.
    • Knowledge in plastic/polymer technology.

    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