Senior QA Engineer — Life Sciences Quality & Compliance

Key Point Life Science Solutions Sdn Bhd; Kulai; On-site; MYR 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Retirement schemes

Training & development

Flexible working

Job summary

Key Point Life Science Solutions Sdn Bhd in Kulai, Johor, is seeking a Senior QA Engineer to lead quality assurance efforts across manufacturing and logistics. You will develop QA programs, perform audits, and drive CAPA initiatives to ensure regulatory compliance and product quality.

The role requires 5–7 years in QA within life sciences, strong analytical skills, and leadership ability to mentor junior staff.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality Management or related field.
• 5–7 years in Quality Assurance, preferably in manufacturing or life sciences.
• Experience with Six Sigma, Lean or similar continuous improvement frameworks.
• Knowledge of ISO 9001, ISO 13485, GMP or FDA requirements.
• Proven experience leading quality audits, investigations and CAPA processes.
• Strong analytical and problem-solving skills.
• Leadership experience to mentor junior team members.
• Proficiency with quality management systems and statistical analysis tools.
• ASQ CQE certification is desirable.
• Supplier quality management and vendor audit experience.

Responsibilities

• Develop, implement, and maintain QA protocols and SOPs for manufacturing and logistics.
• Conduct quality audits, inspections, and testing to identify non-conformances and improvements.
• Lead root cause analyses and CAPA implementation for quality issues.
• Manage supplier quality programs and conduct supplier audits.
• Oversee product testing and validation to meet regulatory standards.
• Prepare and maintain quality documentation for submissions and internal use.
• Train and mentor junior QA staff and promote a culture of quality.
• Collaborate with manufacturing, logistics and operations to resolve issues and optimize processes.
• Monitor quality metrics and report findings to senior management.
• Ensure compliance with ISO, GMP, FDA and life sciences regulations.

Skills

Quality Assurance

Quality Audits

CAPA

Data analysis

Leadership

Supplier quality

Education

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

Tools

Statistical analysis tools

Job description

Key Point Life Science Solutions Sdn Bhd in Kulai, Johor, is seeking a Senior QA Engineer to lead quality assurance efforts across manufacturing and logistics. You will develop QA programs, perform audits, and drive CAPA initiatives to ensure regulatory compliance and product quality.

The role requires 5–7 years in QA within life sciences, strong analytical skills, and leadership ability to mentor junior staff.