QA Engineer

RECRUITPEDIA PTE. LTD.; Singapore; On-site; SGD 42,000 - 65,000; Full time

Job summary

RECRUITPEDIA PTE. LTD. is seeking QA Engineers to support quality assurance activities for a medical device contract manufacturer with operations in Singapore, Malaysia, and China.

The role focuses on ensuring compliance with ISO 13485, monitoring processes, conducting audits, and driving CAPA and documentation improvements within a dynamic manufacturing environment in Singapore.

Qualifications

• Diploma or Degree in Engineering or related field.
• 2–3 years of QA experience in a manufacturing environment.
• Hands-on experience with ISO 13485 Quality Management System.
• Experience in quality audits, CAPA, and quality documentation preferred.
• Strong analytical, problem-solving, and communication skills.

Responsibilities

• Support QA activities to ensure products meet customer and regulatory requirements.
• Monitor manufacturing processes, investigate quality issues, and drive CAPA actions.
• Manage QA documentation, quality audits, product release and inspection activities.
• Liaise with customers, suppliers, and production teams to resolve quality-related issues.
• Analyze quality data and support continuous improvement to ensure ISO 13485 compliance.

Skills

Analytical skills

Problem-solving

Communication skills

Education

Diploma or Degree in Engineering or related

Tools

ISO 13485 QMS

Job description

QA Engineers

Our client is a leading medical device contract manufacturer with operations in Singapore, Malaysia, and China. They are looking for QA Engineers to support quality assurance activities and ensure compliance with medical device quality standards.

Working Hours:

• Monday - Friday, 8:30am - 6:00pm

Job Responsibilities

• Support and oversee Quality Assurance activities to ensure products meet customer and regulatory requirements
• Monitor manufacturing processes, investigate quality issues, and drive corrective and preventive actions (CAPA)
• Manage QA documentation, quality audits, product release, and inspection activities
• Liaise with customers, suppliers, and production teams to resolve quality-related issues
• Analyze quality data, support continuous improvement initiatives, and ensure compliance with ISO 13485 standards

Requirements

• Diploma or Degree in Engineering or a related discipline
• Minimum 2-3 years of Quality Assurance experience in a manufacturing environment
• Hands-on experience with ISO 13485 Quality Management System is required
• Experience in quality audits, process validation, CAPA, and quality documentation is preferred
• Strong analytical, problem-solving, and communication skills

We regret that only shortlisted candidates will be notified.