Senior QA Engineer

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

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Key Point Life Science Solutions Sdn Bhd - Kulai, Johor

Key Point Life Science Solutions Sdn Bhd is seeking a Senior QA Engineer to join our Quality Assurance and Control team. This is a full-time position based in Kulai, Johor, where you will play a critical role in ensuring the highest standards of quality across our manufacturing and logistics operations. As a Senior QA Engineer, you will be responsible for developing and implementing comprehensive quality assurance strategies, leading quality initiatives, and ensuring compliance with industry regulations and standards. This position represents a strategic opportunity to influence product quality, operational excellence, and customer satisfaction across our organisation.

Key responsibilities

• Develop, implement, and maintain quality assurance protocols and standard operating procedures (SOPs) for manufacturing and logistics processes
• Conduct comprehensive quality audits, inspections, and testing to identify non-conformances and areas for improvement
• Lead root cause analysis investigations and implement corrective and preventive actions (CAPA) to address quality issues
• Manage supplier quality management programmes and conduct supplier audits to ensure adherence to quality standards
• Oversee product testing and validation activities to ensure compliance with regulatory requirements and industry standards
• Prepare and maintain quality documentation, records, and reports for regulatory submissions and internal stakeholders
• Train and mentor junior QA staff, fostering a culture of quality throughout the organisation
• Collaborate with manufacturing, logistics, and operations teams to resolve quality issues and optimise processes
• Monitor key quality metrics and performance indicators, reporting findings to senior management
• Ensure compliance with local and international quality standards, including ISO certifications and life sciences regulations

What we're looking for

• Bachelor's degree in Engineering, Life Sciences, Quality Management, or a related discipline
• Minimum 5-7 years of professional experience in Quality Assurance, preferably within manufacturing, pharmaceutical, medical devices, or life sciences industries
• Demonstrated expertise in quality assurance methodologies, including Six Sigma, Lean, or similar continuous improvement frameworks
• Strong knowledge of relevant quality standards and regulations, such as ISO 9001, ISO 13485, GMP (Good Manufacturing Practice), or FDA requirements
• Proven experience in leading quality audits, investigations, and CAPA processes
• Excellent analytical and problem-solving skills with the ability to interpret complex data and draw actionable conclusions
• Strong communication and interpersonal skills with the ability to work effectively across multiple departments
• Leadership experience with the ability to mentor and develop junior team members
• Proficiency in quality management systems and statistical analysis tools
• Certification in Quality Management (such as ASQ CQE or similar) is highly desirable
• Experience with supplier quality management and vendor audit programmes

What we offer

Key Point Life Science Solutions Sdn Bhd is committed to supporting the professional and personal development of our employees. We offer a competitive salary package commensurate with experience, comprehensive benefits including health insurance and retirement schemes, and opportunities for continuous professional development and training. We promote a collaborative work environment where innovation and excellence are valued, and we support work-life balance through flexible working arrangements where applicable. Our organisation invests in employee growth through mentorship programmes, technical training, and career advancement pathways. We maintain a safe, inclusive workplace culture that encourages teamwork and recognises individual contributions.

About us

Key Point Life Science Solutions Sdn Bhd is a leading organisation in the manufacturing, transport, and logistics sector, specialising in life sciences solutions. We are dedicated to delivering high-quality products and services that meet the stringent requirements of the life sciences industry. Our commitment to excellence, innovation, and continuous improvement drives everything we do. We work with customers across the globe to provide reliable, compliant, and efficient solutions. Our team comprises experienced professionals who are passionate about quality and committed to maintaining the highest standards in all our operations. We pride ourselves on our strong safety culture, regulatory compliance, and customer-focused approach.