Formulates procedures, specifications, and standards for Zimmer products and processes.
Develops and implements corrective/preventative action plans.
Provides technical and quality system guidance related to establishing software requirements.
Supports software verification and validation activities for new products in accordance with design planning procedures. This includes, but is not limited to, review and approval of software test case protocols and reports, review of software development plans, and review of other system and software documentation.
Performs risk evaluation and associated management activities related to software development including FMEA, product risk analysis, and mitigation of software issues.
Participates in technical and management reviews to ensure design plans, product design and deliverables related to product software are met. Represents the quality engineering function for the review and approval of designated design outputs.
Supports non-product software validation by assessing the need for validation and preparing and/or supporting protocols, reports and other documentation as required.
May be involved with supporting product cybersecurity assessments in conjunction with a cross-functional team.
Drive best practices for establishing requirements and completing design verification and validation especially as it relates to user needs.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
Performs other related duties and responsibilities, on occasion, as assigned.