Job Description

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Quality Engineering Engineer - Medical Device
Job description
About the roleEstablish the development of quality engineering and quality compliance with the right skill sets for new product introductions and product life cycle management.Implement the strategies for the qualification of the facilities, utilities, equipment, test method and material.
What you'll be doing
Assist in all areas of qualification, validation and calibration in alignment with the ISO 13485:2016 quality management system, US-FDA QSR, European MDR and related International Medical Device Regulations.
Develop Validation Master Plan, impact assessments and validation plans that support the qualification and validation of facilities, utilities, equipment and processes.
Responsible for QMS activities related to new medical device development or product transfer and ensure adequate controls are in place (e.g. new test methods and test specifications).
Support Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Test Method Validation (TMV) and Computer Software Validation (CSV).
Partners with Research Production and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.
Supports new product introduction as part of design transfer and technology transfer activities as required and provide technical assessments on change controls, deviations, and investigations.
Assist in development of validation strategies for the entire process including risk assessment and test method validation.
Work with Procurement to maintain and update approved supplier list.
Work closely with Quality Control team and plan for improvement.
Re-qualification and re-validation of facilities, utilities, equipment and processes as per the frequency established.
Responsible in performing quality inspection for product validation and process validation as part of design transfer and technology transfer activities as required.
Perform any other pertinent responsibility that may be assigned occasionally as required by Top Management or immediate superior.
What we're looking for
Candidate must possess an Associate Degree/Degree in Engineering / Manufacturing/Applied Science/Mathematics or equivalent.
A minimum of 3 years experience working in validations or medical device product testing or equivalent role in a regulated industry (Pharmaceutical or Medical Device manufacturing).
Meticulous at work and result oriented.
Strong organizational skills.
Hands-on knowledge of computer applications including use of the Internet, Word and Excel applications and presentation software such as Power Point and statistical software.
Works well in a team-oriented, cross-functional environment.
Ability to handle multiple tasks and operate in a fast-paced environment.