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.

Authority:

- Approve or reject supplier quality plans, inspection procedures, and test methods.

- Initiate supplier audits and inspections.

- Issue supplier corrective actions report to suppliers.

- Make recommendations for supplier selection, qualification, and development.

- Represent the company in supplier-related meetings and negotiations.

- Approve or reject supplier-related changes or deviations.

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.

. Good command of English language.

. Excellent communication skills

. Strong analytical and problem-solving skills, with the ability to troubleshoot complex issues.

. Able to effectively collaborate with cross-functional teams and present information clearly.

Work Environment:

Controlled Environment (Class 10K/100K cleanroom) and office area. Moderate travelling to supplier site will be required.

Supplier Quality Engineer