Senior Quality Assurance Engineer

Porex Technologies Sdn Bhd (of Filtration Group); Shah Alam; On-site; MYR 40,000 - 60,000; Full time

Job summary

A manufacturing company in Shah Alam is seeking a Process/Quality Assurance professional to qualify and validate manufacturing processes. You will ensure compliance with specifications and regulations, develop quality control methods, and support product launches. An ideal candidate has a background in Industrial Engineering, excellent problem-solving abilities, and relevant certifications such as ASQ or Six Sigma. This role involves continuous improvement initiatives and collaboration with various teams to enhance product quality.

Qualifications

• 2 - 4 years of experience in Process/Quality Assurance.
• Exposure to ISO 9001:2015 QMS and GMP environments.
• Certifications such as ASQ, SPC, Lean, Six Sigma are advantageous.

Responsibilities

• Ensure manufacturing processes meet specifications and regulatory standards.
• Develop and execute validation protocols and quality control plans.
• Work closely with engineering for product launches.
• Conduct root-cause analysis and troubleshooting.
• Perform internal audits for quality management systems.

Skills

Process Improvement

Statistical Analysis

Problem Solving

Education

Degree in Industrial Engineering, Chemistry or Material Science

Tools

Minitab

Optical Measurement Equipment

Tensile Tester

Hardness Tester

Job description

The above employee is responsible to qualify and validate all manufacturing process (including test method, new machine installation and new production introduction) and implement process control based on PFMEA. He/She shall be able to apply relevant QC/QA tools to determine process CTQ and control to assure products and processes are complying with relevant specification. The employee is responsible for continuously improving processes and obtaining optimum product quality by using CAPA methodologies. He/She will work independently to determine appropriate actions to fulfill management objectives and is responsible for supporting the investigation of non-conformances by developing CAPA and using quality tools such as root cause analysis, statistical sampling, capability studies, problem solving, or any other statistical method.

Job Functions include but are not limited to:

Job Functions

• Ensuring that manufacturing processes, equipment, and systems consistently meet required specifications and regulatory standards.
• Develop, implement, and execute validation protocols for equipment, processes, and systems. This includes ongoing verification during commercial production.
• Work closely with Product Development Engineering to launch new products by establishing Process FMEA, Quality Control Plan, Test Method, SOP and Work Instruction.
• Develop, implement and execute Statistical Process Control (SPC) to continuously improve the process control of new and existing products. Knowledge of SPC programs such as Minitab should be an added advantage.
• Develop, implement and execute Test Method Validation such as MSA, GR&R, etc. Knowledge of handling and programming laboratory equipment such as Optical measurement scope, Tensile and Compression Tester, Hardness Tester, Particle Size Analyzer, etc. should be added advantages.
• Perform process troubleshooting and non-conformity root-cause analysis with skills such as 8D Problem Solving, DMAIC, 5Whys, Fish Bone Diagram, etc.
• Perform new machine, process and test method qualification such as Factory Acceptance Test with machine maker and Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ) with Product Development Engineering and Production / Process Teams.
• Lead the training and implementation of new and existing processes to Quality, Production and relevant departments. Establish relevant SOP and WI.
• Handling customer complaints and internal production rejects.
• Perform Internal Audits to continuously improve the production process and Quality Management System. Support and attend external audits.
• Perform other tasks related to QMS and as required by Head of Department.

Job Requirements

Education: Preferably with a Science educated background with a degree in Industrial Engineering, Chemistry or Material Science. Additional processional certifications such as ASQ, SPC, Lean, Six Sigma certifications is an added advantage.

Experience: 2 - 4 years of work experience in Process/Quality Assurance role. Exposure to ISO 9001:2015 QMS, GMP, Automative and Medical products working environment is also an added advantage.

Skills: Ability to work in team concept. Ability to resolve conflicts professionally. Provide/maintain “can-do” attitude with emphasis on customer service.