Responsibilities provide escalation support for significant quality issues ensure timely assessment and containment of quality event participate in mrb activities, ensuring consistent, compliant, and risk-based disposition of nonconforming material own and oversee quality input to post-release design and process changes (ecos, deviations, waivers, temporary changes) ensure thorough change impact assessments are performed to determine verification, validation, revalidation, and documentation requirements ensure appropriate risk controls, benefit-risk justifications, and verification activities are implemented and documented ensure 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 issues ensure supplier changes impacting released products are properly evaluated and approved support strategy for incoming inspection, supplier controls, and quality agreements act as a key quality leader partnering with manufacturing engineering, design engineering, operations, regulatory affairs, clinical, and supply chain lead, mentor, and develop a team of sustaining quality engineers set clear priorities, goals, and performance expectations aligned with business and quality objectives ensure appropriate staffing, training, and skill development to support production needs. Qualifications bachelor's degree or equivalent combination of education and experience in a technical discipline is required. English (fluent) 5 years of experience as a quality manager in the medical, aerospace, or automotive sector. Must have working knowledge of quality systems and practices must be able to provide guidance to functional teams on quality requirements experience in quality systems per iso 13485 ability to work in a project team environment direct experience supporting manufacturing of regulated medical products strong working knowledge of capa, nonconformance management, change control, and root cause analysis excellent verbal and written communication skills excellent prioritizing, organizational, and interpersonal skills excellent documentation skills including detail-oriented, record maintenance/ tracking and understanding of document traceability j-18808-ljbffr