Supplier Quality Engineer

Quasar Medical (Singapore) Pte Ltd; Singapore; Vor Ort; SGD 67.000 - 100.000; Vollzeit

Zusammenfassung

Quasar Medical (Singapore) Pte Ltd is seeking a QA/Supplier Quality professional to lead supplier quality activities. You will drive supplier assessments, audits, CAPA, and risk management across the supply chain to ensure regulatory compliance and high product quality.

The role requires strong collaboration with engineering, procurement, and manufacturing teams, with emphasis on ISO 13485 and FDA standards. Singapore-based position with potential travel.

Qualifikationen

• Regulatory knowledge of FDA and ISO 13485 standards.
• Excellent written and spoken English.
• Strong communication and collaboration across teams.
• Analytical and problem-solving skills; able to troubleshoot complex issues.
• Experience with supplier quality in medical devices preferred.

Aufgaben

• Evaluate suppliers for quality systems, manufacturing capabilities and compliance.
• Manage supplier risk and CAPA through supplier SCAR programme.
• Lead supplier qualification and requalification activities.
• Develop QA plans and conduct supplier audits and inspections.
• Collaborate with engineering, procurement and production to ensure compliant components.
• Prepare monthly/annual quality reports for management.

Kenntnisse

Regulatory knowledge

English proficiency

Communication skills

Analytical thinking

Cross-functional collaboration

Ausbildung

Degree in Engineering or science

Diploma in Engineering or science (5+ years experience)

Jobbeschreibung

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.