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Quality Management Specialist (Medical Devices / $5.5K) (ID: 574855)

Job LocationTampines
EducationNot Mentioned
SalarySGD 5K - 5,500 monthly
IndustryHuman Resources Management / Consulting
Functional AreaNot Mentioned

Job Description

Our client, a well-known company is looking for candidates for the position of Quality Management SpecialistRESPONSIBILITIES ISO 13485 /ISO 9001: Quality Management SystemMaintain the QMS to meet the requirements of the latest ISO 13485/ISO9001Perform Internal Audits to SAP and external audit to Affiliates and BP (when required) according to ISO 13485/ISO9001 requirementsPerform Supplier Audits as and when necessaryConduct Management Review as according to ISO 13485/ISO9001 requirements.Responsible for the internal CAPA process for both factory and office.ISO 14001 Environmental Management SystemMaintain the EMS of SAP to meet the requirements of ISO 14001Perform Internal Audits according to ISO 14001 requirementsConduct Management Review as according to ISO 14001 requirements.Monitoring and improvement of Environmental Management Programs.  Cultivate an environmental mindset in the organizationEnsure waste disposal are done in according to the regulationWorkplace Safety and HealthMaintain and update the risk registers for factory and office.Establish and implement work safety procedures for both factory and office.Conduct Safety Audit for SAP (include offices, training center and WH)To ensure compliance to all necessary regulations such as poison license, hazardous substance license.Establish and implement work safety procedures for both factory and officeHandle and monitor QCHFKeep monitoring customer complain from customers/business partners in AP-GCD regularly.When the complaint is going to be the quality issues, collect enough information and actual stuffs for the investigation by manufacturers and escalate it to the Track Wise (complaint tracking system)Keep contact with manufacturers and complaint sender by closing the issues.Change ControlAct as a coordinator for the Change Control assessment request from S-CorpAssist the Change Control Manager in disseminating the Change Control (CC) information to the appropriate stake holders, serve as coordinator to collect the impact assessment result from the stakeholders and assist the Change Control Manger to consolidate and send back the CC to the manufacturer. Support the CC manager to handle the subsequent CC processes accordingly when needed. Monitor and update the status of the Change ControlREQUIREMENTS Relevant Diploma / DegreeMin. 2 years’ experience in Quality Assurance role in Healthcare industryCertified Lead Auditor for ISO13485/ISO 9001Knowledge and experience in ISO 14001 internal audit and Workplace Safety and Health requirementsISO 13485 / ISO 9001 QMS. ISO 14001 EMSWorkplace Safety and Health Act.Microsoft OfficeCSV knowledge and understanding of CFR 21 part 210, 11 and 820 will be beneficial.Travelling is required.Registration No.: R1983801 (Berlinda Goh)EA License No.: 01C4394 (PERSOLKELLY Singapore PTE LTD)We regret that only shortlisted candidates will be notified.By sending us your personal data and curriculum vitae (CV), you are deemed to consent to PERSOLKELLY Singapore Pte Ltd and its affiliates to collect, use and disclose your personal data for the purposes set out in the Privacy Policy available at You acknowledge that you have read, understood, and agree with the Privacy Policy.

About Company

PERSOL, formerly known as Intelligence, is one of the largest and fastest growing HR service providers in the Asia Pacific regions. With presence in 10 key APAC markets, PERSOL leverages on its strong database of Japanese and Japanese-speaking candidates to provide tailored workforce solutions primarily to Japanese companies in this region. The solutions include permanent and contract staffing, recruitment process outsourcing and payroll outsourcing.The PERSOL brand in Asia Pacific operates under the PERSOLKELLY company, a joint venture between PERSOL Holdings and Kelly Services, forming one of the largest recruitment companies in APAC with its headquarters in Singapore.By sending us your personal data and curriculum vitae (CV), you are deemed to consent to PERSOLKELLY Singapore Pte Ltd and its local and overseas subsidiaries and affiliates to collect, use and disclose your personal data to prospective employers/companies based in any country for purposes of evaluating suitability for employment, conducting reference checks, administering employment related services, complying with Government’s health advisories and such other purposes stated in our privacy policy. Our full privacy policy is available at If you wish to withdraw your consent, please drop us an email to let us know. Please feel free to contact us if you have any queries.Please visit for more information.


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