Supplier Quality Engineer

QUASAR MEDICAL (SINGAPORE) PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading medical device company in Singapore is seeking a Quality Assurance professional to manage supplier quality responsibilities. The role involves supplier evaluations, audits, and ensuring compliance with FDA and ISO 13485 standards. Candidates should have a degree in engineering or science and 2 to 5 years of experience in a similar role. This position offers an opportunity to drive continuous improvement in quality processes.

Qualifications

• 2 - 5 years of progressive quality responsibility in supplier quality for medical devices or pharmaceuticals.
• Knowledge of FDA regulations and ISO 13485 standards.

Responsibilities

• Conduct evaluations of potential suppliers based on quality systems and capabilities.
• Develop and maintain supplier quality assurance plans and procedures.
• Lead supplier audits and monitor performance data.
• Participate in new product introductions ensuring quality compliance.

Skills

Supplier Management

Quality Assurance

Process Improvement

Cross-Functional Collaboration

Education

Degree in Engineering or Science

Job description

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.