Senior Director, Quality

About the Opportunity

We recently announced plans to expand in Spain by building a new, state‑of‑the‑art manufacturing plant in Moncada, Valencia. When it becomes operational in 2026, the plant will manufacture Edwards' surgical and transcatheter heart valve replacement technologies and will join a global network of more than 16,000 talented team members and five other production plants. Our new facility in Moncada will welcome up to 1,500 dedicated team members by 2029 across manufacturing, engineering, and several other professional career paths.

Hiring for professional positions has started and will continue through the winter and early spring, with specialized training for manufacturing hires beginning in the fall of 2025.

• Manage team to ensure smooth and continuous operations in quality.
• Direct a team with responsibilities for quality engineering activities (process and test methods validations, product transfer, process improvements, non‑conformance investigation, corrective action, product disposition, complaint analysis, risk management) with overall responsibility of developing quality processes, staffing, planning, budgeting, aligning priorities, performance management, and working through managers to achieve results.
• Drive a culture that is focused on quality and business results, creating an environment that fosters employee motivation and engagement.
• Plan, prioritize, and direct strategic program activities including product, process, and quality projects using engineering methods (Six Sigma and LEAN) to align with applicable compliance standards.
• Lead in identifying risk, developing complex mitigation strategies, alternative solutions, resolving issues, in collaboration with cross‑functional groups.
• Collaborate with leadership to develop operational strategy and partner with cross‑functional groups to achieve tactical execution of business objectives.
• Provide technical guidance to cross‑functional teams on quality engineering activities that integrate into multiple product lines and systems, including root cause analysis investigations, addressing purchased component quality issues, complaint product evaluations, development and implementation of corrective actions, initiation and approval of product/process changes, and disposition of discrepant material.
• Identify and lead efforts to optimize quality engineering processes and define and implement core competencies, assessing business needs to develop, propose, and implement solution options.
• Develop robust talent development and succession planning in alignment with functional growth strategies across the quality organization.
• Collaborate and align with network and COE teams in driving standardized programs and processes.
• Provide quality engagement to audits, including resources support, technical and procedural expertise, presentation of information, and effective resolution of issues.
• Other incidental duties as assigned.

• Bachelor's Degree in a related field with experience in engineering and skill levels exceeding the requirements of a Senior Manager.
• Experience in Quality Engineering, Quality Management, and/or Regulatory Compliance within the medical device industry.
• Demonstrated track record in managing technical and/or engineering disciplines.
• Experience working in a regulated industry.

• Proven successful project management leadership skills.
• Proven expertise in Microsoft Office Suite and related systems.
• Excellent problem‑solving, organizational, analytical and critical thinking skills, including high discretion/judgment in decision making.
• Excellent documentation and communication skills and interpersonal relationship skills, including negotiation and relationship management abilities to drive achievement of objectives.
• Expert understanding of engineering procedures and the ability to resolve complex problems beyond existing methodologies.
• Expert understanding of related aspects of quality engineering processes and/or systems.
• Expert knowledge of domestic and international regulatory requirements (FDA, GMPs, ISO/EN standards).
• Expert knowledge of design of…