Quality Manager

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 iss