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 jacqueline.goh@talentvue.com.sg

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

Talentvue was started with a single-minded vision in mind: To provide the best-in-class talent acquisition for organisations that go beyond the recruitment process. With over a decade of human capital experience, Talentvue is well-positioned to offer talent sourcing, pre-employment due diligence services and human capital support services to aid you in your transformation journey.