Senior Engineer, Quality Engineering

Quasar Medical; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

Quasar Medical is seeking a Quality Engineer to ensure regulatory compliance and quality throughout the manufacturing process. You will develop QA strategies, oversee production, and support new product transfers with a focus on early quality integration.

The role requires strong problem-solving abilities, cross-functional collaboration, and effective communication in English. Experience in medical device manufacturing and ISO 13485 awareness is essential.

Qualifications

• Degree in Engineering or science; 2–5 years in QA for medical devices/pharma manufacturing, or Diploma with 5+ years QA experience.
• Knowledge of FDA/ISO 13485 and regulatory requirements.
• Strong English communication, analytical and problem-solving skills.

Responsibilities

• Develop, implement, and maintain QA plans, procedures, and controls.
• Monitor production processes to detect quality issues and drive improvements.
• Support audits and regulatory inspections and document findings.
• Lead root-cause analysis and corrective actions for non-conformances.
• Collaborate with customers to understand quality requirements and address feedback.
• Oversee documentation and traceability throughout manufacturing.

Skills

Quality Assurance

Regulatory compliance

Audit readiness

Root cause analysis

Documentation

Education

Engineering or science degree

Diploma in engineering/science (5+ years QA)

Tools

CAPA system

MS Office

Quality management software

Job description

The Quality Engineer is responsible for ensuring the quality and regulatory compliance of medical devices throughout the manufacturing process. This role involves developing and implementing quality assurance strategies, overseeing production processes, managing product quality, and ensuring adherence to industry standards and regulations. This will include support for new product transfers.

Responsibilities

• Quality Assurance and Control:
  • Develop, implement, and maintain quality assurance plans, procedures, and control measures.
  • Monitor and analyze production processes to detect and resolve quality issues.
  • 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 product-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
  • Support validation processes including IQ, OQ, PQ, process validation and test method validation.
  • 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.
  • Address customer complaints and feedback related to product quality.
  • Work closely with customers to understand their quality requirements and ensure that products meet their specifications.
  • Communicate any potential change request of the processes to customer.
  • Provide technical support and quality-related information to customers.
• Documentation and Reporting:
  • Maintain comprehensive records of quality control activities, inspection results, and non-conformance reports.
  • Prepare and support monthly / annual quality reports to management and other stakeholders.
  • Ensure proper documentation and traceability throughout the manufacturing process.
• Training and Development:
  • Train manufacturing staff on quality standards, procedures, and best practices.
  • Promote a culture of quality and continuous improvement within the organization.

Requirements

• Degree in Engineering or science, with 2-5 years of progressive Quality responsibilities, preferably in medical device / pharmaceutical manufacturing. Diploma holders in Engineering or science with more than 5 years experience in Quality may be considered.
• Knowledge of regulatory requirements and quality standards, including FDA regulations and ISO 13485 standards.
• Strong command of the English language.
• 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.

You are applying for Senior Engineer, Quality Engineering in QSG Singapore.