Quality Engineer

2 days ago

Serangoon North, Singapore - HERAEUS MEDICAL COMPONENTS SINGAPORE PTE. LTD. Full time $80,000 - $120,000 per year
Essential Duties and Responsibilities

Quality System Management:

  • Stakeholder in SAP in Quality Module and DMS of site
  • Stakeholder in eQMS of site
  • Ensure that the QMS effectively supports all manufacturing and operational processes, resulting in consistently high-quality product outputs
  • Collaboration with cross-functional teams for document updates

Quality Operation & Lab Management:

  • Support SAP-related activities tied to operational quality
  • Oversee batch review activities including but not limited to incoming, in-process, final inspection, shipment release, and lab testing
  • Oversee the day-to-day operations of the quality control and assurance, ensuring proper procedures and outcomes that consistently align with quality standards and product specifications
  • Manage a team on quality inspection and establishing protocols fulfilling both internal, external customers
  • Ensure compliance with controlled environment standards by monitoring and maintaining cleanroom quality parameters

Equipment Calibration & Measurement System:

  • Site calibration SME and coordinator for both internal and external calibration
  • Ensure timely maintenance and calibration of quality equipment to maintain operational efficiency and compliance with industry standards

Quality Improvement Initiatives:

  • Identify opportunities for process improvements and lead quality improvement projects to enhance manufacturing efficacy and product quality
  • Drive the transformation towards a paperless factory to enhance operational efficiency and data integrity.
  • Implement Statistical Process Control (SPC) to monitor and control quality during manufacturing processes
  • Utilize digital tools and methodologies such as Six Sigma and lean manufacturing to improve productivity and product quality

Team Leadership and Development:

  • Support QA team members, Supervise and manage QA Technicians and Inspectors, providing strategic direction and support whenever needed
  • Conduct and maintain training programs for QA, QC, and production staff. Post-training compliance monitoring and inspector/technician certification maintenance
  • Foster a culture that prioritizes quality and compliance through continuous training, learning and development programs

Stakeholder Engagement and Reporting:

  • Align with the global quality function on strategic global initiatives, ensuring cohesive quality management across the organization.
  • Collaborate closely with manufacturing, R&D, and supply chain departments to ensure alignment on quality standards and to address quality issues promptly
  • Report on quality metrics and KPIs to quality manager, providing insights and recommendations for ongoing quality enhancements

Nonconformance and CAPA Handling:

  • Lead the investigation and resolution of non-conformance issues and product incidents, identifying root causes and implementing corrective actions
  • Lead the development and completion of 8D reports, ensuring thorough documentation and effective resolution of issues
  • Oversee the implementation of corrective and preventive actions (CAPA) to eliminate the causes of potential non-conformities or issues, preventing their recurrence

Environmental Health and Safety (EHS) and Sustainability:

  • Ensure QA activities comply with all applicable EHS regulations, standards, and company policies

Global Quality:

  • Working with peers in Global Quality to drive strategic global initiatives, ensuring cohesive quality management across Medevio Sites

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