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Quality Operations Manager
2 weeks ago
Leading medical device MNC with established manufacturing operations
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
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
Bachelors Degree
Minimum of 10 year(s) experience needed for this position
