Quality Management System (QMS) Engineer

Urgent Featured
  •  
    Boon Keng MRT, Kallang

    Kallang MRT Station (EW10), 5 Sims Avenue, Singapore, 387405

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  •   Full Time
  •   5 Day Week

S$4500 - 5000 / month


RESPONSIBILITIES

  • QMS Compliance: Ensure compliance with medical device regulations and standards across audits, CAPA, change control, documentation, records, and training.
  • Audits: Plan, coordinate and support internal/external audits, including reviewing technical documents and addressing audit findings.
  • Change Control: Manage and coordinate QMS, design and process changes, ensuring proper review, validation/verification, documentation and implementation.
  • CAPA Management: Administer and monitor CAPA activities, including root cause analysis, corrective actions, effectiveness checks and reporting.
  • Document & Records Management: Maintain controlled QMS documents and quality records, including distribution, retrieval, archival and record management.
  • Training & Learning Management: Develop QMS training materials, provide system/user training, manage training records and support staff certification and onboarding.
  • QMS Reporting & Governance: Track QMS KPIs, training status, audit/CAPA/change-control progress and support management review meetings.
  • QMS Improvement & Collaboration: Work with global QMS teams and process owners to harmonize processes, improve QMS systems, and support quality-related projects and initiatives.


REQUIREMENT

  • Education & Experience: Technical/scientific degree with 3+ years of Quality experience in a regulated industry, preferably medical devices/pharmaceuticals.
  • Quality Knowledge: Familiar with cGMP, document/change control, CAPA, Good Documentation Practices and basic problem-solving tools.
  • Technical Skills: Proficient in Microsoft Office; experience with SAP, LMS, MES or electronic document systems is an advantage.
  • Personal Skills: Strong communication, attention to detail, organization, time management, and ability to work independently and in a team.

Do send your resume to:

John - 89686875

Raymond-90091844


About the Employer

REXY MANAGEMENT PTE. LTD.
BRN/UEN: 201200852M
Normally responds in 24 hours



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