Quality Engineer

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

The Quality Engineer will possess the skills and abilities to drive and implement quality assurance initiatives in the MKS Malaysia Supercenter. This role is responsible for ensuring that products meet all internal and external quality requirements, drive product and process

This position requires superior attention to detail and an ability to communicate and solve problems logically and efficiently.

You Will Make an Impact By:

• Leading quality engineering activities related to the manufacturing of one or more product lines to ensure product quality objectives applicable regulatory standards are met.
• Developing, implementing, and maintaining quality control systems and inspection procedures.
• Analyzing manufacturing data and quality metrics to identify trends, root causes, and opportunities for improvement.
• Driving corrective and preventive actions (CAPA) and leading failure investigations using structured problem-solving techniques.
• Collecting and analyzing SPC data and identify appropriate actions when control limits are not met.
• Conducting internal process audits and supporting supplier quality improvement initiatives.
• Participating in risk management activities including PFMEA and control plan development.
• Participating and contributing to Quality Improvement Team (QIT) meetings and initiatives.
• Supporting the product transfer of new product introductions (NPI) through collaboration with the design center to ensure quality requirements and validation protocols are defined and met.
• Supporting MRB activities and the non-conforming material process.
• Overseeing component first article inspection activity.
• Preparing customer facing first article inspection reports (FAIR) and inputting parametric data into customer portals as required.

Skills You Bring:

• A 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.
• Expertise with structured problem solving and experience with 8D, 5-why, Fishbone / Fault tree, PFMEA, K-T, DOE and other problem-solving tools.
• Proficiency in statistical analysis tools (Minitab, JMP) and quality methodologies (Six Sigma, Lean, SPC).
• Working knowledge of quality systems (ISO 9001, ISO 13485, AS9100, etc.). Internal audit experience desired.
• Advanced proficiency in Excel and MS Office applications. Proficiency using Minitab or other statistical tools desired.
• Proficiency with Power BI also a plus.
• Working knowledge of inspection methods, C=0 sampling plans, and use of inspection tools and equipment required.
• Strong interpersonal skills and able to communicate effectively both verbally and written mediums with peers, technicians and management personnel.
• Working knowledge of Oracle ERP and Agile PLM systems a plus.
• Certifications such as CQE, Six Sigma Green/Black Belt are a plus.