Quality Manager

- HERAEUS MEDICAL COMPONENTS SINGAPORE PTE. LTD. – Serangoon

Responsibilities

• Manage and maintain the site's quality management system (QMS) in compliance with ISO 13485 and ISO 9001 and applicable regulatory standards.
• Key stakeholder in ERP in Quality Module and DMS of site.
• Ensure that the QMS effectively supports all manufacturing and operational processes, resulting in consistently high-quality product outputs.

Quality Operation & Lab Management

• Oversee the day-to-day operations of the quality control and assurance, ensuring proper procedures and outcomes that consistently align with product specifications.
• Manage a team on quality inspection and establishing protocols fulfilling both internal and external customers.
• Develop and enforce rigorous lab testing protocols to maintain stringent quality and safety standards.

Capital Expenditure Planning and Equipment Management

• Plan and manage capital expenditure for quality-related equipment in production to support ongoing and new operations.
• 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.

NPI and Quality Engineering

• Ensure compliance with new and pre-existing product requirements.
• Key stakeholder in new product development including qualification to production readiness.

Global Quality

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

Regulatory Compliance and Auditing

• Oversee readiness for all internal and external audits, including customer audits and third-party regulatory audits.
• Lead the preparation and submission of documentation required for regulatory compliance in all markets where products are distributed.
• Develop and implement strategies to manage and reduce compliance risks.

Supplier Management and Incoming Quality Control

• Oversee supplier quality management, conducting audits and addressing issues to ensure supplier compliance with quality standards.
• Develop and maintain strong relationships with suppliers to ensure continuous supply chain improvement and adherence to quality specifications.

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

• Manage and lead a team of skilled quality engineers and technicians, providing strategic direction, training, and development.
• Foster a culture that prioritizes quality and compliance through continuous training, learning and development programs, and succession planning.

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 senior management, providing insights and recommendations for ongoing quality enhancements.
• Communicate effectively with customers and regulatory bodies regarding product quality and compliance issues.

Complaint and CAPA Handling

• Lead the investigation and resolution of non-conformance issues and product incidents, identifying root causes and implementing corrective actions.
• Manage the customer complaint process, ensuring all complaints are addressed promptly and effectively.
• 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

• Support the development, implementation, and enforcement of an EHS policy, complying with all legal and corporate policies.
• Assist in fostering a culture of safety responsibility, providing ongoing training and resources to ensure a safe and healthy work environment.
• Support the establishment and execution of site ESG goals in alignment with Medevio's global sustainability roadmap, ensuring the site contributes effectively to broader corporate sustainability targets.

Qualifications

• Bachelor’s in Engineering or Science / Master’s in Engineering or Science.
• Extensive experience within a manufacturing environment with a thorough understanding of ISO 13485 and ISO 9001.
• Six Sigma certification and/or ASQ certified Quality Engineer.