Quality Management System (QMS) Engineer
-
Boon Keng MRT, Kallang
Kallang MRT Station (EW10), 5 Sims Avenue, Singapore, 387405
- Sepenuh masa
- 5 Hari Seminggu
S$4500 - 5000 / sebulan
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
EMAIL : [email protected]
Tentang Majikan
BRN/UEN: 201200852M
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