Edwards Lifesciences · 10 hours ago
Senior Director, Quality Engineering
USA - Utah – Salt Lake City
Full-time
Onsite
Director/Executive
7+ years expEdwards Lifesciences is a company focused on improving patient outcomes through innovative technologies. They are seeking a Senior Director, Quality Engineering to lead quality operations at their Draper site, ensuring compliance and driving operational excellence. The role involves overseeing a team, optimizing product development processes, and collaborating cross-functionally to support manufacturing and supply chain objectives.
BiotechnologyHealth CareMedicalMedical Device
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
Qualification
Required
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
Preferred
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
Company
Edwards Lifesciences
Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring.
10001+ employees
H1B Sponsorship
Edwards Lifesciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (81)
2024 (70)
2023 (42)
2022 (65)
2021 (44)
2020 (28)
Funding
Current Stage
Public CompanyTotal Funding
unknown2000-04-03IPO
Leadership Team
Bernard J. Zovighian
Chief Executive Officer
Harry Rowland
SVP IHFM Innovation (Implantable Heart Failure Management)
Recent News
Orange County Business Journal
2026-01-14
2026-01-13
Medical Device Network
2026-01-13
Company data provided by crunchbase