Responsible for ensuring product quality and regulatory compliance in medical device manufacturing, including support for new product transfers. Involves monitoring production processes, managing non-conformities, driving quality improvements, and maintaining regulatory standards.
Key Responsibilities
- Develop and maintain quality assurance procedures and control plans.
- Monitor production activities, identify quality issues, and drive timely resolutions.
- Ensure compliance with FDA, ISO 13485, and other regulatory standards.
- Support internal/external audits, regulatory inspections, and validation activities (IQ/OQ/PQ).
- Lead investigations for deviations, non-conformities, and customer-related issues recommend corrective and preventive actions.
- Participate in new product introduction to ensure quality requirements are integrated early.
- Identify opportunities for process improvement and drive cost-saving and efficiency projects.
- Manage quality documentation, inspection reports, NCRs, and monthly/annual performance summaries.
- Communicate directly with customers on complaints, specifications, and change requests.
- Provide training to production teams and promote strong quality culture and compliance.
- Approve quality documents, work instructions, procedures, and risk assessment files.
- Sign off Certificates of Analysis.
Requirements
- Degree in Engineering or Science with 2-5 years of Quality experience (medical device/pharma preferred).
Diploma holders with 5 years relevant experience may be considered. - Strong understanding of regulatory standards (FDA, ISO 13485).
- Good analytical, problem-solving, communication, and cross-functional collaboration skills.
All qualified applicants, please send in your resume to:
[Confidential Information]
Tricia Celestine Goh (R1981653)
Recruit Express Pte Ltd | Company Reg. No. 199601303W | EA License Number: 99C4599
