Quality Engineer

Heraeus; Singapore; On-site; SGD 70,000 - 100,000; Full time

Job summary

A global leader in quality management in Singapore seeks an experienced Quality Assurance Manager to oversee quality operations and lead initiatives aimed at improving product quality. Candidates should have a minimum of 5 years in Quality Assurance within regulated industries and a Bachelor's degree in Engineering or Sciences. The position encompasses responsibilities like managing team performance, ensuring compliance with ISO standards, and driving process improvements.

Qualifications

• Minimum of 5 years of experience in Quality Assurance or Quality Engineering in the medical device or regulated industry.
• Experience within a manufacturing environment with thorough understanding of ISO 13485.
• Hands-on background in operations quality control is preferred.

Responsibilities

• Ensure that the QMS effectively supports all manufacturing and operational processes.
• Lead the investigation and resolution of non‑conformance issues and product incidents.
• Support QA team members and conduct training programs for QA and QC staff.

Skills

Stakeholder engagement

Process improvement

Quality assurance

Calibration and metrology

Team leadership

Education

Bachelor’s degree in Engineering or Sciences or Metrology

Tools

SAP

Statistical Process Control (SPC)

Six Sigma

Job description

Responsibilities

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 establish protocols fulfilling both internal and 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 toward 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

• Work with peers in Global Quality to drive strategic global initiatives, ensuring cohesive quality management across all sites

Qualifications

• Bachelor’s degree in Engineering or Sciences or Metrology, and a minimum of 5 years of experience in Quality Assurance or Quality Engineering in the medical device or regulated industry
• Experience within a manufacturing environment with a thorough understanding of ISO 13485
• Experience in Operational QA, incoming/line release, in‑process controls, environmental monitoring in cleanrooms, nonconformance management, or change control
• Practical experience with measurement equipment
• Skilled in calibration and metrology systems, with hands‑on experience performing equipment calibrations and preparing calibration reports
• Hands‑on background in operations quality control is preferred