QA Engineer - Medical Devices | GMP/ISO Compliance

TestDevJobs; Singapore; On-site; SGD 60,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Annual bonus

Job summary

Thermo Fisher Scientific is seeking a quality assurance professional to ensure regulatory compliance and lead continuous improvement across manufacturing operations. The role focuses on investigations, CAPAs, and maintaining high product quality standards.

You will collaborate with cross-functional teams, manage complaints, and drive process improvements to meet cGMP and ISO requirements in a Fast-paced environment.

Qualifications

• Advanced degree or a bachelor’s with 2 years QA experience in GMP/ISO environments.
• Experience in medical devices, pharmaceuticals or biotechnology preferred.
• ISO 13485/FDA Lead Auditor certification beneficial.
• ASQ CQE/CQA advantageous.
• Strong knowledge of quality systems, cGMP and ISO standards.

Responsibilities

• Ensure compliance with quality standards and regulatory requirements across manufacturing.
• Lead continuous improvement initiatives, investigations, and corrective actions.
• End-to-end complaint handling, trend reporting, and resolution of quality issues.
• Support product qualification, NPI, transfers, supplier quality, deviations and audits.
• Ensure QMS compliance with cGMP, FDA, ISO 13485, MDSAP, IVDR, ISO 9001/14001/45001.

Skills

Quality systems

cGMP knowledge

Regulatory understanding

Root cause analysis

CAPA

Change control

Documented writing skills

Quality tooling

Auditing

Cross-functional collaboration

Statistical analysis

Project management

Education

Advanced degree

Bachelor’s degree + 2 years QA experience

Tools

TrackWise

SAP QM

Microsoft Office

Job description

Thermo Fisher Scientific is seeking a quality assurance professional to ensure regulatory compliance and lead continuous improvement across manufacturing operations. The role focuses on investigations, CAPAs, and maintaining high product quality standards.

You will collaborate with cross-functional teams, manage complaints, and drive process improvements to meet cGMP and ISO requirements in a Fast-paced environment.