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Vice President of Quality Assurance

2 months ago

Salt Lake, Utah, United States Edwards Lifesciences Full time


Oversee and execute a diverse range of initiatives to guarantee that Edwards Lifesciences fosters a culture centered on quality and adheres to global regulatory standards while prioritizing the enhancement of quality engineering methodologies, ensuring compliance, and mitigating risks through the application of Global Policy and Corporate Standard Operating Procedures across designated locations.

Deliver strategic leadership and guidance across various facets of the Quality Management System and tactical execution of associated processes to achieve or surpass client service level agreements, continuous improvement efforts, communication, and organizational quality compliance goals.


Key Responsibilities:

  • Develop and spearhead the implementation of multiple components of Edwards' global quality management framework, emphasizing quality engineering.
  • Provide functional leadership within a culturally and functionally diverse organizational structure. Define overall quality strategy, identify emerging trends, and establish best practices while overseeing quality management operations, including process optimization by assessing needs and leading implementations.
  • Act as a key technical contributor and leader within the QA organization, recognized as an authority in all aspects of global quality assurance and compliance. Plan and direct numerous strategic, enterprise-level projects of utmost importance, including prioritizing and selecting suitable projects.
  • Establish quality enhancement processes in alignment with business objectives, effectively addressing product quality challenges in collaboration with manufacturing and engineering teams.
  • Promote a quality-centric culture through collaboration across the organization. Build relationships with organizational personnel to design Quality programs that cater to the organization's requirements.
  • Manage a critical business function through lower management levels, where the scope and complexity of responsibilities necessitate the integration of multiple disciplines and departments. Recruit, train, manage, and develop Quality professionals to enhance departmental effectiveness and productivity. Assign projects to Quality teams and monitor project progress to ensure the overall workload is adequately addressed. Set operational objectives and delegate tasks to staff.
  • Lead the establishment of key performance indicators for assessing the effectiveness of the quality system and to elevate standards of quality execution.
  • Facilitate the exchange of best practices through management review processes and provide technical assistance to projects in quality and process improvement areas.
  • Conduct analysis of quality data sources to draw insights, identify risks, and propose potential solutions.
  • Perform other incidental duties as required.

Education and Experience:
Bachelor's Degree in a related field with requisite experience and skill levels exceeding those of the Director required.
Experience in the design, development, and implementation of quality-related systems and processes in the medical device sector, utilizing regulations, industry standards, and best practices required.
Master's Degree or equivalent in a related field preferred.

Additional Skills:

  • Demonstrated leadership capabilities with a proven track record in building and engaging high-performing teams, including the ability to collaborate, take initiative, and function as both a team leader and a team member.
  • In-depth knowledge and understanding of FDA GMPs, Medical Device Regulations (EU), and ISO/EN standards.
  • Exceptional analytical skills, along with strong verbal and written communication abilities, teamwork skills, creativity, high energy levels, results orientation, and project management expertise.
  • Proven history of achieving results in terms of efficiency improvements, cost reductions, compliance, and technical excellence, as well as successfully hiring, developing, and leading employees in similar environments.
  • Proficient in Microsoft Office Suite and related tools and systems.
  • Strong problem-solving, organizational, analytical, and critical thinking skills, including high discretion and judgment in decision-making.
  • Expert understanding of quality engineering procedures with extensive knowledge of the company, enabling innovative concepts and the promotion of new ideas.
  • Thorough understanding of related aspects of quality processes and/or systems.
  • Financial acumen as it pertains to engineering.
  • Ability to influence cross-functional partners, business units, and/or sites, and engage with and influence senior management.
  • Capability to develop and integrate metrics into projects and operations that clearly demonstrate the value of engineering to the business.
  • Ability to interact internally and externally with executive-level management, requiring negotiation of highly critical matters and influencing policy-making.
  • Capacity to cultivate peer, cross-functional, and cross-business relationships to maximize best practice sharing and team effectiveness.
  • Provide leadership and direction to large cross-functional teams to successfully implement global enterprise solutions.
  • Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety regulations) and take appropriate measures to prevent injuries to oneself and others, as well as to protect the environment and prevent pollution within their span of influence/control.
Edwards Lifesciences is an Equal Opportunity/Affirmative Action employer, including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards Lifesciences is dedicated to safeguarding our vulnerable patients and the healthcare providers caring for them. Consequently, all patient-facing and in-hospital positions necessitate COVID-19 vaccination.

If hired into a covered role, as a condition of employment, you will be required to provide proof of COVID-19 vaccination unless you request and are granted a medical or religious exemption from the vaccination requirement.

This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.