Responsibilitiesprovide escalation support for significant quality issuesensure timely assessment and containment of quality eventpartner with r&d to embed quality and manufacturability into new product designssupport design controls for development and sustaining changesparticipate in design reviews with a strong focus on producibility and riskensure design changes are manufacturable, verifiable, and compliantsupport verification & validation activities with production-representative buildssupport risk management (dfmea, use-related risk, production risk inputs)investigate design-related production issues and quality escapestranslate production floor feedback into actionable r&d design improvementsensure design documentation and traceability (dhf, requirements, v&v) are audit-readysupport audits and inspections related to design controlsparticipate in mrb activities, ensuring consistent, compliant, and risk-based disposition of nonconforming materialensure sustained compliance with applicable regulations and standards, including iso 13485, fda 21 cfr 820 (qsr), eu mdr (as applicable), and relevant iec standards (e.g., iec 60601-1)collaborating with supplier quality and supply chain leadership on supplier-related quality issuesqualificationsa/bs degree, or equivalent combination of education and experience in a technical discipline is required3+ years of experience in design quality engineering, product quality, or manufacturing quality within a regulated industrymust have working knowledge of quality systems and practicesmust be able to provide guidance to functional teams on quality requirementsexperience in quality systems per iso 13485ability to work in a project team environmentdirect experience supporting manufacturing of regulated medical productsstrong working knowledge of capa, nonconformance management, change control, and root cause analysisexcellent verbal and written communication skillsexcellent prioritizing, organizational, and interpersonal skillsexcellent documentation skills including detail-oriented, record maintenance/ tracking and understanding of document traceability
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