Quality Engineer (Fresh Grads welcome!)

Essential Duties and Responsibilities:

1. Ensure Product Quality meets requirements:

1. Review and improve manufacturing Quality operations, Quality trends of product (process & final) and maintain Product Quality thru re-training and CIAs.
2. Identify improvement areas and recommendation of Quality improvement processes to manufacturing and liaise with Mfg/ Mat. personnel to reinforce GMP/ GDP requirements.

1. Equipment and Process Validation:

1. Initiate studies to validate and evaluate equipment & processes (New) and monitoring of equipment and processes to identify areas for continuous improvements.
2. Establish specifications, Quality acceptance criteria and Inspection methods for routine manufacturing operations.

1. Failure Analysis for Equipment, Process and Product:

1. Identify root causes of problem and initiate corrective/ preventive actions and liaise with divisional staff on technical & Quality issues and review SOPs, specifications, changes for adequacy and Quality requirements.

1. Customer Complaints Handling and Feedback:

1. Evaluation of customer complaints- internal feedback initiation and implement corrective/ preventive actions.

1. Introduction of New Products/ Changes:

1. Communicate, co-ordinate, plan and execution of requirements during FOC run. Conduct stability study where applicable.

1. Product sterilization meets sterility requirements. Sterilization system management and maintenance activities meets specification requirements (Steam sterilization- Quality Engineer):

1. Ensure sterilizers/ cycles qualifications are completed per requirements and coordinate with Microbiologist/ chemists to perform required tests and monitoring activities.
2. Review impact of product, equipment, process changes to sterilizer qualification status and changes to Vessel (EOM) and to ensure required tests and documentation are complete.
3. Review sterilization process, coordinate with process owner to ensure compliance and participate and review sterilization exception and continuous improvement.
4. Coordinate with Microbiologist/ chemists to perform required tests and monitoring activities and ensure equipment used for sterilization qualifications calibrated/ validated and maintained.

1. Managed assigned Projects:

1. Plan, organise, execute and monitor projects.

1. Six Sigma Process Control:

1. Evaluate, install and monitor SPC processes.

1. Responsible for compliance to EHS procedure and requirement.

Qualifications/ Education:

• Diploma/ Degree in Engineering (Mechanical/ Production) or equivalent

Skill Set and/or Experience:

• Fresh Degree/ Diploma with Min 3 years or
• Degree with Min 3 years/ Diploma with Min 6 years
• Knowledge on Quality systems, engineering, management
• Statistical knowledge- SPC, DOE, sampling methodology
• Computer skills, SPC software, etc and process understanding and validation
• Metrology, usage and set-up of measuring equipment