Responsibilitiesprovide escalation support for significant quality issuesensure timely assessment and containment of quality eventparticipate in mrb activities, ensuring consistent, compliant, and risk-based disposition of nonconforming materialown 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 requirementsensure appropriate risk controls, benefit-risk justifications, and verification activities are implemented and documentedensure 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 issuesensure supplier changes impacting released products are properly evaluated and approvedsupport strategy for incoming inspection, supplier controls, and quality agreementsact as a key quality leader partnering with manufacturing engineering, design engineering, operations, regulatory affairs, clinical, and supply chainlead, mentor, and develop a team of sustaining quality engineersset clear priorities, goals, and performance expectations aligned with business and quality objectivesensure appropriate staffing, training, and skill development to support production needs.qualificationsbachelor'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 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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