The Senior Quality Engineer will play a pivotal role in site process improvement activities and operations support for our Dispensing products. Reporting to the Quality Engineering Manager, duties include: management and approval of process validation studies, active participation in non-conformance investigations and leading process improvement projects. The role also involves the management of continuous improvement projects, and application of SPC to current production processes.
Provide ongoing software quality engineering support throughout the software development life cycle. Provide support to development, engineering and manufacturing functions for validation planning and transfer activities.
Provide quality leadership to new product development teams in the areas of design control, design verification and validation, design transfer, process validation, risk management, and specification development.
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.
Oversee test planning and execution, implementation, and release to production.Coordinate with QA, Development and Product Management Leads to ensure proper delivery and execution of product/feature deliverables.