Senior QC Engineer – Medical Devices & CAPA Lead
Recruit Express Pte Ltd
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Job summary
Recruit Express Pte Ltd is seeking a QC/Quality Engineer in Singapore to lead investigations into product quality issues, manage NC/OOS investigations and CAPA, and perform QC data trending to drive process improvements. The role requires strong hands-on experience with ISO 13485 and regulatory exposure is a plus.
The candidate will work closely with Manufacturing and Engineering to support validation activities and troubleshooting of QC instruments, contributing to ongoing quality improvements
Qualifications
- Min degree in Chemistry, Biochemistry, Biological Science, Life Science or related field.
- Min 3–10 years of QC / Quality Engineering experience in IVD, diagnostics, medical devices, biopharma or life-science manufacturing.
- Strong hands-on experience in NC/OOS investigations and CAPA.
- Experience in validation and QC instrument troubleshooting.
- Good knowledge and understanding of ISO 13485 is essential.
- MDSAP / GMP regulatory exposure advantageous.
- Able to connect laboratory issues with manufacturing quality investigations and drive resolution independently.
Responsibilities
- Lead investigations into product quality issues and drive them to closure
- Manage NC / OOS investigations, CAPA and quality notifications
- Perform QC data trending and identify process / test improvements
- Support customer complaint investigations and failure analysis
- Troubleshoot QC instruments and laboratory / test issues
- Work closely with Manufacturing and Engineering on quality improvement
- Support process, method and equipment validation activities
Skills
Education
Tools
Job description
Recruit Express Pte Ltd is seeking a QC/Quality Engineer in Singapore to lead investigations into product quality issues, manage NC/OOS investigations and CAPA, and perform QC data trending to drive process improvements. The role requires strong hands-on experience with ISO 13485 and regulatory exposure is a plus.
The candidate will work closely with Manufacturing and Engineering to support validation activities and troubleshooting of QC instruments, contributing to ongoing quality improvements
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