The primary responsibility of this position is to provide leadership for all Quality Assurance & Control matters.
This includes:
- Assuring consistent quality of production by developing processes and enforcing compliance to ISO 13485 quality system.
- Validating the production & inspection processes and maintaining validation status
- Managing the records for Quality Inspection, Quality Control, Calibration, QA Lab equipment, Training Resources, ERP Quality Module and Quality System Documentation.
- Managing a team of Engineers, QA Technicians & Quality Inspectors
The incumbent reports to the Site Leader, Singapore and Global Head of Quality (Medevio).
Roles & Responsibilties
Quality System Management
- 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, 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
