Senior QA Engineer - Life Sciences (ISO/GMP, CAPA Lead)

Key Point Life Science Solutions Sdn Bhd; Kulai; Sur place; MYR 120 000 - 180 000; Plein temps

Avantages offerts par ce poste

Health insurance

Retirement schemes

Training and development

Flexible working arrangements

Résumé du poste

Key Point Life Science Solutions Sdn Bhd is seeking a Senior QA Engineer to join our Quality Assurance and Control team in Kulai, Johor. You will develop QA strategies, lead quality initiatives, and ensure compliance with ISO, GMP, and regulatory standards across manufacturing and logistics.

You will manage audits, CAPA investigations, supplier quality programs, and document control while mentoring junior staff and driving continuous improvement throughout the organization.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality Management, or a related discipline.
• Minimum 5-7 years of professional experience in Quality Assurance, preferably in manufacturing, pharmaceutical, medical devices, or life sciences industries.
• Demonstrated expertise in quality assurance methodologies such as Six Sigma and Lean.
• Strong knowledge of ISO 9001, ISO 13485, GMP, or FDA requirements.
• Proven experience leading quality audits, investigations, and CAPA processes.
• Excellent analytical and problem-solving skills; strong cross-functional collaboration.

Responsabilités

• Develop, implement, and maintain QA protocols and SOPs for manufacturing and logistics.
• Conduct audits, inspections, and testing to identify non-conformances and improvement areas.
• Lead root cause analyses and implement CAPAs.
• Manage supplier quality programs and conduct supplier audits.
• Oversee product testing and validation for regulatory compliance.
• Prepare quality documentation for regulatory submissions and internal stakeholders.
• Train and mentor junior QA staff and promote a quality culture.
• Collaborate with manufacturing, logistics, and operations to resolve quality issues.

Connaissances

Quality management

Analytical thinking

Leadership

Communication

Formation

Bachelor's degree in Engineering/Life Sciences/Quality Management

Outils

Statistical analysis tools

Description du poste

Key Point Life Science Solutions Sdn Bhd is seeking a Senior QA Engineer to join our Quality Assurance and Control team in Kulai, Johor. You will develop QA strategies, lead quality initiatives, and ensure compliance with ISO, GMP, and regulatory standards across manufacturing and logistics.

You will manage audits, CAPA investigations, supplier quality programs, and document control while mentoring junior staff and driving continuous improvement throughout the organization.