Sr. Supplier Quality Engineer/Supplier Quality Engineer

Quasar Medical; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading medical device company in Singapore is seeking a Quality Assurance Specialist to oversee supplier evaluations, ensure compliance with regulatory standards, and drive quality improvement initiatives. The ideal candidate will have a degree in engineering or science and possess strong analytical and communication skills. This role requires 2 - 5 years of experience in a similar position, focusing on quality assurance in the medical device sector.

Qualifications

• 2 - 5 years of progressive Quality responsibility, preferably in Supplier Quality in medical device or pharmaceutical manufacturing.
• Knowledge of FDA regulations and ISO 13485 standards.
• Good command of English language.

Responsibilities

• Conduct evaluations of suppliers based on quality systems and capabilities.
• Develop and maintain supplier quality assurance plans.
• Lead supplier audits and inspections.

Skills

Supplier evaluation

Risk management

Quality assurance

Analysis

Communication

Problem-solving

Education

Degree in Engineering or Science

Job description

Responsibilities

• 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 the 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.
• 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.
• 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 projects.

Documentation and Reporting

• Prepare and support monthly / annual quality reports to management and other stakeholders.
• Ensure proper documentation and traceability throughout the manufacturing process.

Collaboration 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 reports 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 of 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.