The Quality Engineer's primary responsibilities are to support new software product development activities, maintain compliance to company procedures and external standards, manage design history files, review verification and validation documentation, participate in risk analysis activities, collaborate on product development deliverable documentation and support the creation of 510k packages. Responsibilities also include being the quality and compliance representative in the assigned teams.
This position is responsible for equipment, facilities, utilities and automation qualification activities in a cGMP environment. The candidate should have a strong background in Automation Validation. This position will coordinate, validate and manage projects related to equipment implementation and manufacturing process changes.
The Senior Quality Engineer will play a pivotal role in site process improvement activities. Reporting to the Quality Engineering Manager, duties will include management and approval of process validation studies, active participation in non conformance investigations and leading process improvement projects.
Lead resolution to product complaints and/or safety issues, and collaborates with other functions to improve customer satisfaction, and deliver products that meet or exceed customer needs and expectations.
Support interdisciplinary product development team to ensure design/development procedures, design controls, supplier controls and test requirements are conducted in compliance with applicable standards and that they are fulfilled.