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senior/qa engineer (medical devices).

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 QA/Compliance Manager, you will:

    • Be responsible for the implementation of the Plant’s quality system in accordance with international standards (such as ISO 13485, etc) and Quality System Requirements (QSR) of various regulatory agencies
    • Lead and/or work with cross functional teams to ensure product quality and quality system requirements are fulfilled
    • Develop and implement policies / procedures to ensure Plant’s Quality System complies with 21 CFR Part 820 – Quality Systems Regulation, ISO13485, Medical Devices Directive (93/42/EEC), Medical Device Regulations (Canada) and any other applicable standards
    • Support opportunities for continual improvement and QA Engineering initiatives in respective functions
    • Lead the quality audit program in the plant to ensure consistency of documented procedures and operations
    • Provide quality engineering support on External Quality Audits, Supplier Audit program and Customer Audit.
    • Provide support on product / process qualifications by ensuring quality requirements are fulfilled.

    job requirement

    • Diploma in Engineering
    • Minimum 3 years of experience in a manufacturing environment, particularly, quality related areas.
    • Certified Lead / Internal Auditor for ISO 13485.
    • Experienced in ISO 13485; 21 CFR 820 quality system audit is essential.
    • Familiarity with analytical and statistical tools
    • 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 QA/Compliance Manager, you will:

    • Be responsible for the implementation of the Plant’s quality system in accordance with international standards (such as ISO 13485, etc) and Quality System Requirements (QSR) of various regulatory agencies
    • Lead and/or work with cross functional teams to ensure product quality and quality system requirements are fulfilled
    • Develop and implement policies / procedures to ensure Plant’s Quality System complies with 21 CFR Part 820 – Quality Systems Regulation, ISO13485, Medical Devices Directive (93/42/EEC), Medical Device Regulations (Canada) and any other applicable standards
    • Support opportunities for continual improvement and QA Engineering initiatives in respective functions
    • Lead the quality audit program in the plant to ensure consistency of documented procedures and operations
    • Provide quality engineering support on External Quality Audits, Supplier Audit program and Customer Audit.
    • Provide support on product / process qualifications by ensuring quality requirements are fulfilled.

    job requirement

    • Diploma in Engineering
    • Minimum 3 years of experience in a manufacturing environment, particularly, quality related areas.
    • Certified Lead / Internal Auditor for ISO 13485.
    • Experienced in ISO 13485; 21 CFR 820 quality system audit is essential.
    • Familiarity with analytical and statistical tools
    • 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