Senior QA Engineer (Medical Device)

Key Responsibilities

• Monitor product and process quality, investigate non-conformances, and implement corrective and preventive actions (CAPA).
• Ensure compliance with FDA, ISO 13485, and company quality management system requirements.
• Support internal audits, external audits, and regulatory inspections.
• Participate in product transfers, new product introductions (NPI), and validation activities (IQ/OQ/PQ, process and test method validation).
• Conduct root cause analysis and drive continuous improvement initiatives to enhance quality and manufacturing performance.
• Manage customer quality issues, complaints, and change notifications.
• Maintain quality documentation, reports, and traceability records.
• Train and support manufacturing teams on quality standards and best practices.

Requirements

• Degree or Diploma in Engineering, Science, or a related discipline.
• 2–5 years of quality experience in medical device, pharmaceutical, or regulated manufacturing environments.
• Knowledge of FDA regulations, ISO 13485, CAPA, root cause analysis, and quality management systems.

Kindly email your resume in a comprehensive Word format to [email protected]

We regret to inform that only shortlisted candidates will be notified.

Please be informed that by applying for the advertised position, the candidate is considered to have given their consent for us to collect, utilize, or disclose their personal information for the purposes related to the services we provide.

Jacqueline Goh

EA License Number: 22C1430

Registration Number: R1326664