Director, Quality

Edwards Lifesciences

About The Position

Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world. The Director of Quality is a people leader responsible for managing the Receiving Inspection team and ensuring the effective operation of the site’s quality management system. This role oversees quality control and quality assurance activities related to incoming materials, ensuring uninterrupted operations and compliance with internal and regulatory standards. The Director of Quality leads process audits, oversees part release documentation, and provides guidance on failure investigations and corrective actions. This position also advises on compliance methodologies for incoming materials and works cross-functionally to drive continuous improvement across quality processes.

Requirements

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.

Nice To Haves

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.

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.