Quality Engineering Engineer – Medical Device

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).
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