Experteer Overview In this role you drive quality engineering across a new Moncada manufacturing site, aligning quality programs with regulatory standards and business goals. You lead cross-functional teams to implement robust processes, risk mitigation, and continuous improvement, ensuring compliant, high-quality production of heart valve technologies. You will shape a quality-focused culture, develop talent, and partner with leadership to execute strategic initiatives at scale. This is a pivotal role for delivering reliable life‑saving devices in a fast-paced environment.
Compensaciones / Beneficios • Lead quality engineering activities across product lines, including validation, non-conformance investigations, CAPA, product disposition, and risk management • Direct and develop teams with responsibilities for process and test methods validations, product transfer, and quality projects • Plan and execute strategic quality programs using Six Sigma and LEAN to meet compliance and business objectives • Collaborate with cross-functional groups to identify risks, develop mitigation strategies, and resolve complex issues • Provide technical guidance for root cause analysis, supplier quality, complaint evaluations, and change control • Develop core quality competencies, optimize processes, and implement solutions addressing business needs • Drive talent development, succession planning, and alignment with functional growth strategies • Partner with network and COE teams to standardize programs and drive enterprise-wide quality initiatives • Support audits by providing resources, expertise, and issue resolution • Manage performance, budgeting, priorities, and staffing to achieve results • Support and participate in integral enterprise system implementations • Maintain strong relationships with senior leaders and external stakeholders • Adhere to safety, environmental, and company policies and procedures • Other incidental duties
Responsabilidades • Bachelor's Degree in related field with experience in engineering (senior level) • Experience in Quality Engineering, Quality Management, and/or Regulatory Compliance within the medical device industry • Proven track record in managing technical and/or engineering disciplines • Experience working in a regulated industry
Requisitos principales •