Quality Engineer III

Job description

Job DetailsJob Location: Xeridiem - Tucson - Tucson, AZ 85714Position Type: Full TimeJob Shift: 1st ShiftJob Purpose: Serve as a senior-level Quality Engineer with leadership responsibilities in medical device QMS compliance, strategic quality initiatives, and cross-functional project execution. Drive continuous improvement in product quality, regulatory compliance, and risk management across the product lifecycle. Act as a subject matter expert (SME) in core QMS elements and global regulatory standards. ESSENTIAL DUTIES: Lead large-scale or cross-functional quality projects involving product lifecycle management, validation, CAPA, audit readiness, risk management, or supplier quality improvement. Act as a quality lead on new product development or design transfer projects, ensuring compliance with design control and risk management requirements. Develop and implement risk management strategies in accordance with ISO 14971 and maintain risk files throughout product lifecycle. Provide expert-level input on process validation and sterilization validation strategies, including complex or novel technologies. Lead internal and supplier audits and actively support external audits (FDA, I...