The Quality Manager will be responsible for implementing and maintaining an effective quality management system for the Singapore discrete manufacturing site that complies with Medical Device Single Audit Program (MDSAP) requirements. This individual will function as a senior leader who collaborates with other functional managers to establish strategic quality plans and lead the organization as a change agent in building a culture of quality and compliance. The candidate must demonstrate excellent leadership, communication, critical thinking, judgement and organizational skills. It is expected that this position will lead a team-based organization in a matrix environment where employees are flexible and empowered to make decisions appropriate for their level. How You’ll Make an Impact: Develop, implement and maintain effective and MDSAP compliant quality system processes. Develop and lead quality assurance function/team and QMS strategic quality planning processes. Collaborate with other GSC sites, local functions, R&D teams and QA organizations to determine approaches to achieve local and global quality objectives. Oversee ongoing collection, analysis and communication of QMS performance data. Ensure reporting aligns with global corporate measures. Promote use of risk-based approaches to support transfer and manufacturing activities. Lead by example to use of sound investigation and corrective action methods and statistical techniques. Guide and approve CAPA risk assessments, correction, containment and communication in response to identified performance issues. Communicate quality-related regulatory requirements to the management team and greater organization. Serve as Senior Management Representative for the Quality Management System ensuring the QMS is effective and meets customer and regulatory requirements. Serve as QA/RA contact with outside regulatory agencies and other external parties during inspections and audits. What You Bring: While this list of qualif
SGD 16,000 - 19,000 / Monthly
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