Job Description

Job Functions include but are not limited to:

• 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 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.
• Software proficiencies: intermediate user level:  Minitab, MS Office, e-mail; basic user level: instrumentation programming.

Skills