- Well Established Company
- Basic $5000 - $6500 + Allowance + AWS + Variable Bonus
- Excellent Welfare and Benefits + Career progression
- Working location: Boon Lay
- Working day: Monday to Friday
- Working hours: 8.30am to 5.30pm
- ISO:13485 | Product Quality Control | Process Improvement
Job Responsibilities:
Supplier Quality:
- Assess, qualify, and monitor supplier performance; address and resolve supplier quality issues.
- Drive supplier improvement actions through CAPA and performance reviews.
Customer Complaints:
- Handle customer feedback and complaints; lead investigations and root cause analysis.
- Ensure timely resolution and customer satisfaction.
Product Quality & Validation:
- Review and approve incoming, in-process, and final product inspections.
- Verify and validate new parts and materials; approve Certificates of Conformance (COC) and Certificates of Analysis (COA).
Process Improvement:
- Identify quality issues and drive continuous improvement using CAPA, FMEA, and other quality tools.
- Lead process optimization and defect reduction initiatives.
Compliance & Audits:
- Support internal and external audits; ensure compliance with ISO 13485, FDA regulations, and company standards.
- Review and approve Device History Records (DHR) and related documentation.
Data Analysis & Reporting:
- Analyze quality data, track metrics, and report progress on quality objectives to management.
Change Management:
- Manage change control processes and ensure proper documentation for all product/process changes.
Job Requirements:
- Possess minimum Diploma/Degree in relevant subject area with minimum 3 years’ experience in medical device QA and/or RA
- ISO 13485:2016 certified internal auditor will be advantageous
- Familiar with quality control tools
Candidates are encouraged to apply this position via Apply Now button with the following information in the resume
- Work experiences and job responsibilities
- Current and Expected salary
- Reason for leaving
- Date of availability
- Education background
We regret that only shortlisted candidates will be contacted.
NG DIAUM YEE (R2198031)
EA Recruitment Pte Ltd
EA License No: 21C0492
