Working with cross-functional teams across the company to create world class technical solutions to help with testing; responsible for advocating quality centric processes within the development and testing teams.
This role will work seamlessly with related Quality, Engineering and Business groups to ensure timely responses for customer Quality requests, such as handling field returns, supporting customer audits and other compliances needs.
Manage overall programs and processes; including process improvement development, validation (e.g. software such as SFDC, e-QMS) and implement compliant and effective complaint handling and CAPA subsystems.
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.
The Senior Software Quality Assurance (SQA) Engineer ensures software quality within complex medical device products throughout the entire product development lifecycle, and owns the development and execution of software test plans by way of verification procedures based upon software and system specifications.
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.
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.
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.
Work with engineers, team leads, managers to help developing innovative testing solutions that meet market needs with respect to functionality, performance, scalability, reliability, realistic implementation schedules, and adherence to testing goals and principles.