Quality Engineering Engineer – Medical Device

Pentamaster Corporation Berhad; Bayan Lepas; On-site; MYR 60,000 - 90,000; Full time

Job summary

Pentamaster Corporation Berhad in Penang, Bayan Lepas is seeking a Quality Engineering Engineer – Medical Device to drive quality engineering and compliance for new product introductions and lifecycle management across our manufacturing operations.

You will lead qualification, validation and calibration activities, support QMS tasks for device development and transfer, and partner with suppliers and internal teams to ensure robust processes, risk management and regulatory readiness.

Qualifications

• Associate Degree or Degree in Engineering or equivalent.
• Minimum 3 years in validations or medical device testing in regulated industry.
• Meticulous, well-organised and strong team collaboration.

Responsibilities

• Assist in qualification, validation and calibration per ISO 13485, US-FDA QSR and MDR.
• Develop validation master plan and plans for facilities, utilities, equipment and processes.
• Support QMS activities for new device development or transfer and ensure controls.
• Support DQ/IQ/OQ/PQ, TMV and CSV activities.
• Collaborate with suppliers and internal teams on process validation and risk management.
• Assist in change controls, deviations and investigations.
• Plan for validation strategies and supplier qualification.
• Re-qualify and re-validate facilities, utilities and equipment as scheduled.

Skills

Validation

Quality Engineering

Regulatory Compliance

ISO 13485

QMS

Teamwork

Education

Engineering degree

Tools

Excel

PowerPoint

Job description

Quality Engineering Engineer – Medical Device

About the role
Establish 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.

PENTAMASTER CORPORATION BERHAD, a Malaysian investment holding company listed on the Main Board of Bursa Malaysia Securities Berhad, is one of the global leaders in providing advanced, world-class manufacturing automation solutions & services to help worldwide customers meet their productivity challenges & maintain the edge required for success in a competitive business environment.

Through our subsidiaries, we provide an integrated range of innovative services in technological solutions, manufacturing of automated & semi-automated machinery & equipments, designing & manufacturing of precision machinery components, as well as design, assembly & installation of computerized automation systems & equipments.

With more than 25 years of experience in dealing with high-end technology companies across worldwide markets, we are confident to compete in terms of manufacturing flexibility, quality services, cost-effective solutions, timely delivery & positioned for greater growth.

History

Check our website http://www.pentamaster.com.my under 'Milestones'

Product & Services

Standard Semiconductor Back-end Equipment. Customized Automated Solutions. Vision Inspection System. Material Handling Solutions. Test and Measurement System. High Precision Components Manufacturing. Equipment Contract Manufacturing. Shopfloor Management System. RFID Application Solutions. Logistics and Warehouse Solutions.

Vision

To provide world class automation solutions to the Manufacturing Industries in the Global Market

Mission

We are dedicated in delivering high quality and cost effective products with value-added services. In our effort to meet our mission, we strive to provide benefits and satisfaction to our customers, vendors, employees and the community as a whole.

PENTAMASTER CORPORATION BERHAD, a Malaysian investment holding company listed on the Main Board of Bursa Malaysia Securities Berhad, is one of the global leaders in providing advanced, world-class manufacturing automation solutions & services to help worldwide customers meet their productivity challenges & maintain the edge required for success in a competitive business environment.

Through our subsidiaries, we provide an integrated range of innovative services in technological solutions, manufacturing of automated & semi-automated machinery & equipments, designing & manufacturing of precision machinery components, as well as design, assembly & installation of computerized automation systems & equipments.

With more than 25 years of experience in dealing with high-end technology companies across worldwide markets, we are confident to compete in terms of manufacturing flexibility, quality services, cost-effective solutions, timely delivery & positioned for greater growth.

History

Check our website http://www.pentamaster.com.my under 'Milestones'

Product & Services

Standard Semiconductor Back-end Equipment. Customized Automated Solutions. Vision Inspection System. Material Handling Solutions. Test and Measurement System. High Precision Components Manufacturing. Equipment Contract Manufacturing. Shopfloor Management System. RFID Application Solutions. Logistics and Warehouse Solutions.

Vision

To provide world class automation solutions to the Manufacturing Industries in the Global Market

Mission

We are dedicated in delivering high quality and cost effective products with value-added services. In our effort to meet our mission, we strive to provide benefits and satisfaction to our customers, vendors, employees and the community as a whole.