Serves as the primary quality lead for project activities to achieve on-time quality deliverables, high customer value, and profitable results. Primary driver for the quality and compliance aspects of the project.
Assures proper integration and support of device regulations, drug regulations, and as appropriate, biologics regulations. Responsible for compliance with company policies and procedures.
Ensures design control documentation (Traceability/Linkages) & design change control requirements are met. Assesses the impact of a change on the safety, efficacy of the combination product/device. Analyzes and justifies the impact on cumulative changes.
Education & Experience:
5+ years of total combined experience. At least 3 years in Device Design Quality Assurance
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