Quality Engineer (Validation)

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We believe in the power of diversity and inclusion and cultivate a workplace culture of belonging that views uniqueness as a competitive edge and builds a community that enables our people to push the limits of innovation to make great products that create value and improve people's lives.

A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary.

Job Summary

To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a Quality Engineer (Validation) located in Senai, Johor.

What a typical day looks like:

• Well verse in GMP procedures and validation requirements and experience at gathering technical information from vendors and scientific literature
• Serves as the validation coordinator on selected project teams.
• Ensures validation including protocols and reports compliance to site requirements and all applicable ISO 13485, FDA Quality System Regulation, cGMP requirements and any other applicable regulations.
• Develop validation master plan and validation protocols (IQ/OQ/PQ), write test scripts and lead process validation activities for various manufacturing processes
• Assists in the review and validation of process changes including protocols and report for completeness, accuracy and compliance to the site requirements, FDA Quality System Regulation, and ISO 13485 Standard.
• Interface with all medical customers to provide Flex Medical and Site compliance on validation overview including equipment qualification, change control.
• Assists to ensure a GMP compliance culture, and auditing program including corrective action process.
• Assess change controls, facility work orders and equipment risk assessments to ensure compliant/validate state of all GMP equipment and systems
• Ensures that validation activities, protocol, report, and execution are being carried out in compliance to site and regulatory requirements.
• Perform deviation investigations and help to implement CAPA and re-validation as necessary

The experience we’re looking to add to our team:

• Possesses a Degree in related discipline or equivalent experience.
• Minimum 5 years of working experience in the related field is required

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