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Manager, Supplier Quality Engineering Location US-WA-Bothell ID 2025-1671 Category Quality Assurance/Regulatory Affairs Position Type Full Time Work Model Onsite Company Overview Verathon is a global medical device company focused on supporting customers by being their trusted partner, delivering high-quality products that endure over time and ensure clinical and economic utility. Two areas where Verathon has significantly impacted patient care, and become the market leader in each, are bladder volume measurement and airway management. The company's BladderScan portable ultrasound and GlideScope video laryngoscopy & bronchoscopy systems effectively address unmet needs for healthcare providers and meaningfully raise the standard of care for patients. Verathon, a subsidiary of Roper Technologies, is headquartered in Bothell, Washington, USA and has international subsidiaries in Canada, Europe and Asia Pacific. For more information, please visit www.verathon.com. Overview Verathon is looking for a Manager, Supplier Quality Engineering to become the newest member of our Quality Assurance Team located in Bothell, WA. The Manager of Supplier Quality Engineering is responsible for managing, improving, and maintaining the Verathon Global Supplier Quality Program. Responsibilities * Set strategy for global Supplier Quality organization * Provide leadership to Supplier Quality Engineers; manage performance through clear goal and expectation setting, accountability, and feedback; maximize the contributions of team members by proactively developing talent * Manage team performance through KPIs/metrics that track team activities and deliverables * Represent Verathon as the primary liaison with contract manufacturers and suppliers for all quality and compliance activities * Develop and implement effective Quality Management System (QMS) processes in compliance with governing regulations and international standards: FDA Quality System Regulations (QSR, 21 CFR Part 820), Canadian Medical Device Regulations (CMDR, SOR 98-292), EU Medical Device Regulation (2017/745), ISO13485, and ISO14971 * Mitigate risks that may affect product quality or regulatory compliance * In partnership with Supply Chain Management, improve and manage processes to select new suppliers * Manage component qualification /Production Part Approval Process (PPAP) in alignment with New Product Development and Sustaining Engineering timelines; Ensure adequate process development and validation (IQ/OQ/PQ) occurs for suppliers' manufacturing processes * Define and execute a risk-based Supplier Quality Audit program; Conduct audits of suppliers to assess the robustness of their Quality Systems, controls, and ability to deliver quality parts * Manage supplier-caused non-conforming material (NCM) through Return to Vendor (RTV) and the Supplier Corrective Action Request (SCAR) processes * Lead investigation and correction of product quality issues * Ensure suppliers properly execute responsibilities under the Supplier Change Notification (SCN) process * Manage tools and mechanisms for ensuring supplier performance (Supplier Quality Agreements and Supplier Scorecards) * Lead continuous improvement in QMS and suppliers' manufacturing processes * Leverage lean and six sigma methodologies. Qualifications * Bachelor's degree and 8+ years of Quality experience (including 4 years' experience in supplier quality roles) or master's degree and 6+ years of Quality experience * 3+ years prior experience as a people leader * Bachelor's degree required * Mechanical, Electrical, or Biomedical Engineering or Business Management (Supply Chain) Degree is preferred * Experience in Aerospace (AS9145 APQP/PPAP) or medical device