- Drive quality excellence in a growing medical technology environment
- Lead process improvements and influence cross‑functional decisions
About Our Client
Our client is a global medical technology manufacturer known for delivering high‑precision products used in healthcare settings worldwide. They are expanding their quality function and seeking experienced professionals who can elevate operational standards and support long‑term growth.
Job Description
- Oversee quality management systems and ensure strong regulatory compliance across manufacturing operations
- Develop, implement, and maintain quality assurance procedures aligned with FDA, ISO 13485, and other relevant standards
- Support both internal and external audits, ensuring all documentation and processes meet compliance requirements
- Monitor production processes to identify quality gaps and resolve issues proactively
- Conduct product investigations, lead root‑cause analysis, and implement effective corrective and preventive actions (CAPA)
- Support new product transfers by ensuring quality requirements are built into early development and production phases
- Lead validation activities including IQ, OQ, PQ, process validation, and test method validation
- Drive continuous improvement initiatives to enhance product quality and operational efficiency
- Manage customer feedback and complaints, ensuring timely resolution of quality‑related concerns
- Communicate any necessary process changes or updates to customers and internal teams
- Provide technical guidance and quality‑related support to internal and external stakeholders
- Maintain accurate quality documentation, inspection records, and monthly/annual quality reports
- Train manufacturing personnel on quality procedures, standards, and best practices
- Promote a strong culture of compliance, quality ownership, and continuous improvement
The Successful Applicant
- A degree in Engineering or Science, Diploma holders with extensive experience
- Quality experience, preferably in medical devices
- Strong knowledge of FDA regulations and ISO 13485
- Strong analytical and problem‑solving skills with a structured approach to troubleshooting
- Ability to collaborate effectively with cross‑functional teams and communicate clearly
- Experience working in cleanroom or controlled environments is an advantage
What's on Offer
- Opportunity to drive quality excellence in a regulated and fast‑growing sector
- Exposure to new product transfer projects and key validation activities
- Collaborative work culture and cross‑functional project involvement
- Career growth in an established, innovation‑driven medical technology organisation
Contact
Vanessa Chan (Lic No: R2197577/ EA no: 18S9099)
Quote job ref
JN-032026-6959737
Phone number
+65 6643 9742
Michael Page International Pte Ltd | Registration No. 199804751N
