Quality Manager
5 days ago
Leading medical device MNC with established manufacturing operations
Location: Paya Lebar
- Lead the quality team on operations and process compliance issues
- Investigate on non-conforming product / materials & collaborate with process owners to drive for timely disposition
- Coordinate on root-cause analysis (RCA tools) on non-conformance, risk assessment and initiate corrective and preventive action
- Establish, review and approve methods and procedures for evaluating, measuring, controlling and monitoring product and processes that meet quality standards and regulatory authorities requirement
- Ensure reports are technically well-written, risk assessed, strong justification and aligned on quality engineering specification & requirements.
- Chair quality meeting and provide reports for defect trend, analysis and investigation to the Operations and Engineering teams while recommending improvement
- Partners with engineers on testing at in-coming, in-process and out-going to ensure compliance to quality standards
- Guide and coach Quality Operations teams on improvement projects and other initiatives
Requirement
- Degree in Engineering (Mechanical, Material, Polymer)
- At least 10 years of quality engineering / operations work in a MNC manufacturing environment in the medical devices industry with proven people management experience
- Experience and hands on in quality inspections, measurement techniques and experiences in failure analysis
- Comprehending technical drawings and specifications
- Experience in aseptic environment, cleaning, and hygiene regulations
- Knowledge in process validation and computer system validation
- Continuous Improvement (CI) experience and trained in six sigma or lean manufacturing will be preferred
- Knowledge of ISO 13485 with preferred ISO 13485 Lead auditor / knowledge in FDA inspection
- Statistical and Analytical methods
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