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Validation Engineer at Cochlear - ApplyBlast

Validation Engineer

Cochlear

3 months ago

3.6 on Glassdoor

Kuala Lumpur, Malaysia

Onsite

Full Time

Senior

0 applicants

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About this role

As a Validation Engineer at Cochlear Malaysia, you will support the quality and compliance of manufacturing operations by executing validation activities for processes, equipment, and facilities. You will collaborate with cross-functional teams to ensure products meet regulatory standards through design transfer, equipment qualification, and continuous improvement initiatives within a regulated medical device environment.

Responsibilities

Plan and execute validation activities for manufacturing processes and equipment
Prepare and review validation documentation including protocols and risk assessments
Support design transfer and new equipment installation qualification
Ensure compliance with Quality Management Systems and regulatory requirements
Partner with cross-functional teams to provide validation expertise and guidance

Skills

Qualifications

Bachelor's degree in Mechanical, Chemical, or Industrial EngineeringKnowledge of ISO 13485 and FDA 21 CFR Part 820

About Cochlear

cochlear.com

Headquarters

North Ryde, New South Wales, Australia

Company Size

1001-5000 employees

Founded

1981

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Cochlear is a leader in hearing device implants that help to restore hearing and connect people to a world of sound. Start your hearing journey today!