Essential Duties and Responsibilities:
Include the following. Other duties may be assigned.
. Supplier Management:
- Conduct thorough evaluations of potential suppliers based on quality systems, manufacturing capabilities, and compliance history.
- Assess supplier performance and capabilities to ensure they meet or exceed company quality standards.
- Collaborate with suppliers to identify and implement improvement initiatives to enhance quality and efficiency.
- Provide technical guidance and support to suppliers to address quality issues and drive continuous improvement.
- Assess and manage supplier risks, including supply chain disruptions, quality deficiencies, and regulatory non-compliance.
- Develop and implement risk mitigation plans to minimize potential negative impacts.
- - Build and maintain strong relationships with suppliers to foster collaboration and trust.
- Communicate effectively with suppliers to address quality concerns and ensure mutual understanding.
- Drive all supplier corrective and preventive action through supplier SCAR programme in a timely manner to ensure robust and effective action are in place.
- Lead and drive all supplier qualification and requalification activities
. Quality Assurance and Control:
- Develop, implement, and maintain supplier quality assurance plans, procedures, and control measures.
- Maintaining Approved Vendor / Supplier List.
- Conduct or oversee supplier audits and inspections to verify compliance with quality standards and regulatory requirements.
- Monitor and analyze supplier performance data to identify trends and areas for improvement.
- Ensure compliance with relevant regulatory requirements, including FDA, ISO 13485, and other applicable standards.
- Support internal and external audits and regulatory inspections.
- Investigate and resolve supplied material-related issues, deviations, and non-conformities, with the authority to recommend corrective and preventive actions.
- Ensure the non-conformance or quality issue is resolved and complete in a timely manner.
- Participate in new product introductions to ensure quality is built into all products early in their life cycle
- Investigate and resolve non-conforming materials from suppliers, including root cause analysis and corrective actions.
- Implement effective containment strategies to prevent the release of defective products.
- Manage the supplier change process and ensure the implementation of the change has minimum impact to the production.
. Process Improvement:
- Identify opportunities for process improvements to enhance product quality and manufacturing efficiency.
- Lead and drive QA initiatives across the product areas
- Lead or participate in root cause analysis and corrective action planning.
- Support and drive cost improvement project
. Documentation and Reporting:
- Prepare and support monthly / annual quality reports to management and other stakeholders.
- Ensure proper documentation and traceability throughout the manufacturing process.
. Collaborate with Cross-Functional Teams
- Work closely with engineering, procurement, and production teams to ensure seamless integration of supplier components into our manufacturing processes while maintaining compliance with quality standards.
Education/Experience and Qualifications:
- Degree in Engineering or science, with 2 - 5 years of progressive Quality responsibility, preferably Supplier Quality in medical device / pharmaceutical manufacturing. Diploma holders in Engineering or science with more than 5 years experience in Supplier Quality, may be considered.
- Knowledge of regulatory requirements and quality standards, including FDA regulations and ISO 13485 standards.
