Senior Quality Engineer - Medical Devices QA & Regulatory

quasar medical medical device manufacturer; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Quasar Medical, a medical device manufacturer in Singapore, is seeking a Quality Engineer to ensure quality and regulatory compliance across manufacturing processes. You will develop QA plans, oversee production quality, and support audits and product transfers.

The role requires 2–5 years in quality, knowledge of FDA/ISO 13485, strong problem-solving skills, and excellent English communication. You will work in a controlled environment and collaborate with cross-functional teams to drive

Qualifications

• Degree in Engineering or science with 2–5 years of quality responsibility.
• Knowledge of regulatory requirements including FDA and ISO 13485.
• Strong analytical and problem-solving skills.
• Good command of English.

Responsibilities

• Develop, implement, and maintain quality assurance plans, procedures, and control measures.
• Monitor and analyse production processes to detect quality issues and deviations.
• Ensure compliance with regulatory requirements and support audits and inspections.
• Investigate and resolve non-conformities and implement corrective actions.
• Support new product introductions to ensure quality built in from early stages.
• Participate in process validation including IQ, OQ, PQ and method validation.
• Identify opportunities for process improvements to enhance quality and efficiency.
• Address customer complaints and ensure products meet specifications.
• Maintain records of quality activities and prepare monthly/annual quality reports.
• Train staff on quality standards and promote continuous improvement.

Skills

Quality assurance

Regulatory compliance

Root cause analysis

Process improvement

Cross-functional teamwork

Education

Degree in Engineering or Science

Diploma in Engineering or Science

Job description

Quasar Medical, a medical device manufacturer in Singapore, is seeking a Quality Engineer to ensure quality and regulatory compliance across manufacturing processes. You will develop QA plans, oversee production quality, and support audits and product transfers.

The role requires 2–5 years in quality, knowledge of FDA/ISO 13485, strong problem-solving skills, and excellent English communication. You will work in a controlled environment and collaborate with cross-functional teams to drive