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.
The Senior Quality Engineer chairs meetings to analyze and identify trends in process parameters, defective material or finished product as well as systemic issues, and coordinates improvement actions following methodologies such as 8D (8 Discipline), problem solving techniques and root cause analysis.
Perform routine and non - routine analytical biochemical and molecular biology assays to support release, characterization and stability testing of raw materials, production intermediates and final goods.
In this role, the selected candidate will participate in Agile Scrum sprint planning, design history creation, in-sprint testing, automated regression testing, demonstrations, retrospectives, and solution releases.
Leads and coordinates activities with cross functional teams to achieve and ensure that quality standards are met within a Quality Management System. Investigates and establishes causes for repetitive or excessive discrepancies using problem solving and statistical process control techniques.
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.