Senior Director, Quality Engineering

Edwards Lifesciences•Draper, UT

About The Position

Imagine how your ideas and expertise can change a patient's life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You'll bring your passion for problem solving and partner with various teams to influence decision-making for a product's entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. We are seeking a dynamic Senior Director, Quality Engineering to lead quality operations at our Draper site. This role is pivotal in ensuring compliance, driving operational excellence, and serving as the subject matter expert for audits and inspections. The Senior Director will oversee a large, matrixed team of managers and engineers, champion validation strategies, and partner cross-functionally to support manufacturing and supply chain objectives. If you are passionate about quality leadership in the medical device industry and thrive in a fast-paced environment, we want to hear from you. How you'll make an impact: Direct a team with responsibilities for quality engineering activities (e.g., 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. Create an environment that fosters employee motivation and engagement. Plan, prioritize, and direct strategic program activities including product, process, and quality projects using engineering methods (e.g., Six Sigma and LEAN methods) to align with applicable compliance standards. Lead in identifying risk, developing complex mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional groups. Collaborate with leadership to develop operational strategy. Partner with cross-functional groups/resources 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/or systems with significant complexity 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, by 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/or processes. Provide quality engagement to audits including resources support, technical and procedural expertise, presentation of information, and effective resolution of issues. Other incidental duties

Requirements

Bachelor's degree in engineering or scientific field
Experience in quality engineering activities and/or manufacturing operations within the medical device industry; or equivalent work experience based on Edwards' criteria.
Demonstrated track record in people management and leading large teams
In-depth knowledge of ISO 13485, FDA Quality System Regulations (QSR), and global regulatory requirements.

Nice To Haves

Exceptional leadership skills with at least seven (7) years of experience managing people leaders and large quality engineering teams in a matrixed organization.
Proven expertise in CAPA management and process validations (IQ/OQ/PQ).
Proven ability to oversee nonconformance handling, including NCRs and product complaint investigations.
In-depth knowledge of risk management principles (ISO 14971) and application in product and process design.
Proficiency in quality metrics and continuous improvement methodologies, including Lean Six Sigma, Design of Experiments (DOE), and process capability analysis.
Skilled in audit readiness and leadership, including FDA inspections, notified body audits, and internal audits.
Demonstrated success in supplier quality oversight, ensuring incoming components meet specifications and compliance standards.
Demonstrated ability to lead cross-functional teams and drive continuous improvement initiatives.
Excellent communication and collaboration skills to influence cross-functional teams and drive operational excellence.

Responsibilities

Direct a team with responsibilities for quality engineering activities (e.g., 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.
Create an environment that fosters employee motivation and engagement.
Plan, prioritize, and direct strategic program activities including product, process, and quality projects using engineering methods (e.g., Six Sigma and LEAN methods) to align with applicable compliance standards.
Lead in identifying risk, developing complex mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional groups.
Collaborate with leadership to develop operational strategy.
Partner with cross-functional groups/resources 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/or systems with significant complexity 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, by 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/or processes.
Provide quality engagement to audits including resources support, technical and procedural expertise, presentation of information, and effective resolution of issues.
Other incidental duties