Senior Quality Assurance Engineer

Porex; Selangor; On-site; MYR 150,000 - 200,000; Full time

Job summary

A manufacturing company located in Malaysia seeks a Quality Assurance Specialist to qualify and validate manufacturing processes and implement process controls. The role involves developing validation protocols, conducting root cause analyses, and improving product quality. Ideal candidates will have a background in Industrial Engineering, Chemistry or Material Science, with 2-4 years of relevant experience in quality assurance and knowledge of ISO 9001:2015. Strong teamwork and customer service skills are also essential.

Qualifications

• Bachelor's degree in a relevant field is preferred.
• 2-4 years of experience in Process/Quality Assurance role.
• Knowledge of ISO 9001:2015 QMS, GMP

Responsibilities

• Qualify and validate manufacturing processes and equipment.
• Implement process control methods like PFMEA.
• Develop and execute Test Method Validation.

Skills

Team collaboration

Conflict resolution

Customer service

Education

Degree in Industrial Engineering, Chemistry or Material Science

Tools

Statistical Process Control (SPC)

Root Cause Analysis

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

• Ensuring manufacturing processes, equipment, and systems consistently meet required specifications and regulatory standards.
• Develop, implement, and execute validation protocols for equipment, processes, and systems, including 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.
• Develop, implement and execute Test Method Validation such as MSA, GR&R, etc.
• 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).
• 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.