Quality Engineer: CAPA & Process Improvement Lead

MKS Instruments, Inc.; Batu Kawan; On-site; MYR 65,000 - 85,000; Full time

Job summary

MKS Instruments, Inc. Malaysia is seeking a Quality Engineer to drive and implement QA initiatives in our Malaysia Supercenter. The role ensures products meet internal and external quality requirements, drives improvements, and maintains high customer satisfaction.

You will lead QC activities for multiple product lines, develop inspection procedures, and analyze data to identify trends and root causes. Strong problem-solving and communication skills are essential for success in this role.

Qualifications

• Bachelor's degree in engineering or equivalent.
• 2+ years in a quality engineering role, preferably in regulated industries.
• Experience in semiconductor capital equipment is a plus.
• Strong knowledge of quality engineering disciplines and methodologies.
• Expertise with structured problem solving (8D, 5-why, Fishbone).
• Proficiency in statistical analysis tools (Minitab/JMP) and Six Sigma/Lean/ SPC.
• Familiarity with quality systems (ISO 9001, ISO 13485, AS9100).
• Internal audit experience is desirable.
• Advanced Excel and MS Office skills; Power BI is a plus.

Responsibilities

• Lead quality engineering activities for manufacturing product lines to meet quality objectives and regulatory standards.
• Develop, implement, and maintain QC systems and inspection procedures.
• Analyze manufacturing data and quality metrics to identify trends and root causes.
• Drive CAPA and lead failure investigations using structured problem solving.
• Collect and analyze SPC data and take action when control limits are breached.
• Conduct internal process audits and support supplier quality improvements.
• Contribute to PFMEA and control plan development and QIT initiatives.
• Support product transfers of new product introductions with design teams.
• Oversee MRB activities and non-conforming materials handling.
• Prepare and submit first article inspection reports (FAIR) and record data in customer portals.

Skills

Quality engineering

CAPA

8D

PFMEA

DOE

Minitab

Power BI

Excel

STATISTICAL

Education

Bachelor's degree in engineering

Mathematics/Statistics/Physics/chemistry/material science

Tools

Minitab

JMP

Power BI

Excel

Oracle ERP

Agile PLM

Job description

MKS Instruments, Inc. Malaysia is seeking a Quality Engineer to drive and implement QA initiatives in our Malaysia Supercenter. The role ensures products meet internal and external quality requirements, drives improvements, and maintains high customer satisfaction.

You will lead QC activities for multiple product lines, develop inspection procedures, and analyze data to identify trends and root causes. Strong problem-solving and communication skills are essential for success in this role.