Generates Risk Management Files (pFEMA) to new ISO 14971 standard. Helps execute Validation of equipment and Processes (test method validation.) Monitors, inspects, and evaluates products to ensure predetermined quality standards are met. Develops and updates testing-related documentation, including test cases, plans, and flaw-reporting procedures.Hybrid Work Model - Start more onsite at beginning and then can work remote as needed. Must be able to come onsite as HM requires. Could be 5x a week some weeks, or remote 5x a week. Must have flexibility. RESPONSIBILITIES: Recommend process/quality improvements as part of validation runs. Evaluate, investigate and document non-conformances incidents and/or protocol deviations. Complete assigned Non-Conformance and CAPA investigations and prepare investigation reports. Develops and maintains an effective cross-functional working relationship with plant and corporate Manufacturing, Engineering, Regulatory, Design Assurance, Product Development and Quality Assurance personnel. Work on project teams with other internal departments, external vendors, and customers as required. Assure that existing processes and assigned activities fully comply with regulatory and/or international agencies, such as FDA, ISO, OSHA, EPA, among others. Participate in the compilation and review of technical documentation for both domestic and international regulatory submissions. Participate in external audits such as: FDA, Notified Body (BSI) and Corporate, among others. Performs other related duties as necessary.