Edwards Lifesciences · 17 hours ago
Director, Quality
USA - Utah – Salt Lake City
Full-time
Onsite
Director/ExecutiveEdwards Lifesciences is a company focused on delivering solutions for patients with cardiovascular disease. The Director of Quality is responsible for managing the Receiving Inspection team and ensuring effective operation of the site's quality management system, overseeing quality control and assurance activities, and driving continuous improvement across quality processes.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Provide strategic leadership to supervisors and the Receiving Inspection organization, ensuring operational excellence across all inspection activities, production lines, and assigned projects. Build a high‑performing team through proactive talent development, succession planning, and capability building aligned with departmental and organizational growth strategies
Oversee and govern key Quality Assurance initiatives, including CAPA, nonconformance management, and root‑cause investigations. Maintain accountability for meeting all project deliverables within defined timelines and quality standards. Anticipate risks, develop mitigation strategies, evaluate alternatives, and drive cross‑functional alignment to ensure timely and compliant issue resolution
Set direction and expectations for the inspection, verification, and acceptance of incoming materials and components. Ensure that processes are executed consistently and in accordance with the Quality Management System, regulatory requirements (e.g., FDA QSR/cGMP), and internal procedures
Influence and collaborate effectively across the enterprise - including Manufacturing Operations, Supply Chain, Engineering, and Supplier Quality - to address complex quality challenges, negotiate solutions, and drive sustainable improvements that enhance product quality and operational efficiency
Champion continuous improvement by identifying systemic opportunities within the QMS, incoming inspection processes, and supplier-related workflows. Lead the implementation of strategic initiatives that strengthen compliance, reduce risk, improve throughput, and support long-term organizational objectives
Serve as a key Quality Leader by providing expert guidance, coaching, and decision support across cross-functional teams. Represent the Quality function in site-level planning, audits, and strategic discussions to ensure alignment with business priorities and regulatory expectations
Perform other duties and responsibilities as assigned
Qualification
Required
Bachelor's Degree in related field and skill levels exceeding the requirements of the Superintendent or equivalent work experience based on Edward's criteria
Experience in managing internal audit programs and inspections/audits by external regulatory agencies for class II/III medical devices or equivalent work experience based on Edwards criteria
Demonstrated track record in people management or equivalent work experience based on Edwards criteria
Up to 10% of domestic and international travel
Preferred
Success leading complex, cross‑functional quality initiatives, with strong project management leadership skills and the ability to drive execution, manage risk, and deliver results aligned with business objectives
Excellent written and verbal communication skills being influential with all stakeholders
Deep understanding in quality procedures, process, and systems
Expert knowledge of applicable quality regulations and standards, including cGMP and other FDA regulated requirements
Strong financial acumen, including resource planning, risk mitigation, and operational efficiency
Proven people leadership capability, including direct management of teams and leaders, performance management, coaching and development
Working knowledge of Lean Manufacturing and Six Sigma methodologies
Demonstrated ability to influence change by leveraging credibility, data, and strategic relationships to drive adoption of quality initiatives across the organization
Advanced proficiency in Microsoft Office, and experience utilizing electronic Quality Management Systems (eQMS) and data analysis tools to support reporting, trending, and decision‑making
Company
Edwards Lifesciences
Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring.
Founded in 1958
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
Andrew Greene
Vice President, Strategy
Recent News
bloomberglaw.com
2026-01-20
BioWorld Financial Watch
2026-01-15
Orange County Business Journal
2026-01-14
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