• Continuously fully comply with all GMP standard /ISO 13485 requirements.
• Maintain the local Quality system and implement all quality requirements in the supplier development and supplier quality management areas. Conduct monitoring and trend analysis for Quality System implementation in the supplier management.
• Provide guidance on Quality Assurance/GMP/FDA-QMSR related topics.
• Responsible to stop further processing in the event of encountering non-conforming products condition.
• As owners of SNCRs and SCARs, develop, coordinate and/or implement root cause problem solving, preventive and corrective actions. Analyzes reports and/or returned products and recommends corrective action. Ensure timely support to resolve and close supplier related non-conformances.
• Follow supplier performance monitoring program and quality objectives and makes sure that targets are achieved by monitoring performance/trending against defined parameters.
• Attend external audits and support internal audits.
• Supplier assessments and provide variety of sourcing support activities
• Support Product verification, Process validation, Reliability testing and Component qualification.
• Responsible for Supplier process controls and surveillance.
• Drive supplier performance improvements. Lead supplier certification process.
• Work with operational and other functional stakeholders (quality, supply chain, operations, finance) on the screening, qualifying, auditing and supporting of the suppliers for new components, commodities, manufacturing capabilities or assemblies/finished products; on-going relationship management and improvement of supply chain performance.
• Ensure that the validated manufacturing processes are adhered to and any changes are communicated in advance and in accordance with our company established standards.
• Other tasks assigned by Supervisor.
