Quality Engineer: Lead QA, CAPA & Continuous Improvement

MKS Inc.; Penang; On-site; MYR 60,000 - 120,000; Full time

Job summary

MKS Inc. in Malaysia is seeking a Quality Engineer to drive QA initiatives in the manufacturing environment and ensure products meet internal and external quality requirements. You will lead CAPAs, process audits, and PFMEA while collaborating with design and supplier quality teams.

The role emphasizes structured problem solving, statistical analysis, and proficiency with quality systems. Strong communication skills and attention to detail are essential for success.

Qualifications

• Bachelor's degree in engineering, mathematics, statistics, physics, chemistry, material science, or equivalent.
• 2+ years of experience in a quality engineering role, preferably in a regulated industry (e.g., medical devices, aerospace, automotive). Prior experience in semiconductor capital equipment industry is a plus.
• Strong knowledge of quality engineering disciplines, tools and methodologies.
• Proficiency with structured problem solving (8D, 5-Why, Fishbone, PFMEA, DOE).
• Proficiency in statistical analysis tools (Minitab, JMP) and quality methodologies (Six Sigma, Lean, SPC).
• Working knowledge of quality systems (ISO 9001, ISO 13485, AS9100).

Responsibilities

• Lead quality engineering activities for manufacturing to meet quality objectives and regulatory standards.
• Develop, implement, and maintain quality control systems and inspection procedures.
• Analyze manufacturing data and quality metrics to identify trends and root causes.
• Drive CAPAs and lead failure investigations using structured problem-solving techniques.
• Collect and analyze SPC data and take actions when control limits are not met.
• Conduct internal process audits and support supplier quality initiatives.
• Participate in PFMEA and control plan development.
• Participate in QIT meetings and initiatives.
• Support product transfers for new product introductions with the design center.
• Support MRB activities and non-conforming material processes.
• Oversee first article inspection activities.
• Prepare FAIR reports and input data into customer portals.

Skills

Quality engineering

Problem solving

Statistical analysis

Excel

MS Office

Communication

Quality systems

ISO 9001/13485/AS9100

Minitab

JMP

Education

Bachelor's degree in engineering

Tools

Minitab

JMP

MS Excel

Job description

MKS Inc. in Malaysia is seeking a Quality Engineer to drive QA initiatives in the manufacturing environment and ensure products meet internal and external quality requirements. You will lead CAPAs, process audits, and PFMEA while collaborating with design and supplier quality teams.

The role emphasizes structured problem solving, statistical analysis, and proficiency with quality systems. Strong communication skills and attention to detail are essential for success.