Senior QA Engineer

Key Point Life Science Solutions Sdn Bhd; Kulai; Vor Ort; MYR 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Health insurance

Retirement schemes

Training and development

Flexible working arrangements

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Quality management

Analytical thinking

Leadership

Communication

Ausbildung

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

Tools

Statistical analysis tools

Jobbeschreibung

About the role

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.