Engineer, Quality

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Engineer, Quality

Baxter International

Marsa, Malta

The Quality Engineer has the following main responsibilities to ensure compliance to ISO13485:

Support process developments and process changes to ensure these are validated effectively in manufacturing, Also gaining in depth knowledge of the processes and be a key role in pFMEAs and their start-up in manufacturing.
Support change controls/design changes to ensure these are transferred in manufacturing with the right set-up to prevent manufacturing issues or complaints from the customers. This is done through assessments, process validations, pFMEAs, design transfers and related tasks.
Perform process validations as deemed necessary.
Perform test method validations documentation and execution in the quality labs, and ensure these are done in a timely and compliant manner.
Conduct Master Validation Plan periodic reviews and closure of any gaps identified as applicable.
Ensure Data Integrity compliance and provide support in Computer Systems Validations.
Ensure compliance to customer and regulatory requirements and Baxter Quality Management System standards.
Work closely with the Engineering teams to ensure that process issues are resolved.
Conduct internal audits and in-process assessments.
Support TuV and corporate audits and any action items triggered during these audits.
Ensure Environmental Health and Safety requirements procedures are adhered to in order to reach EHS targets and not jeopardize the health and safety of employees and environment.
Ensure compliance to Good Documentation and Manufacturing Practices (GDPs and GMPs). Support Manager in other responsibilities, as needed.