Edwards Lifesciences IT Manager, Quality Management Systems in Irvine, California
The IT Manager for Quality Management Systems (QMS) will be responsible for planning and directing the project portfolio and service delivery for the global Quality and Compliance systems. They will lead a team of IT professionals to resolve business problems, improve business processes, develop systems and policies, improve user proficiency, and promote system adoption in collaboration with key stakeholders and IT. The IT Manager will be closely aligned with domestic and international stakeholders in supporting its members, collaborating closely with both groups to successfully deliver results. This role will report to the Sr. IT Manager Responsibilities:
Manage experienced IT professionals to deliver the QMS project portfolio and service delivery.
Act as the Business Relationship Manager and point of contact between the QMS teams, business partners, and IT service providers.
Align new and existing technology with business practices and objectives by developing and maintaining end to end business processes.
Manage the Quality Systems service delivery catalog for the Quality business applications and technologies to ensure performance according to business needs and IT standards.
Plan and direct project activities with the accountability for successful completion of all project deliverables to the business within established financial, schedule, scope, and quality objectives.
Assess new technologies and methods to meet the business partners’ needs.
Up to 25% domestic and international travel, approximately one week per quarter depending on projects and workflow.
A Bachelor’s degree in Computer Science, or a related field, with a minimum of 10 years of experience working with quality systems within a manufacturing environment is required.
An MBA or Master's degree in Computer Science, or related field, with a minimum of 8 years of experience working with quality systems within a manufacturing environment is preferred.
Must have a minimum of 5 years of people management experience with 3 or more direct reports.
Expert understanding of IT procedures while addressing issues with impact beyond own team based on knowledge of related disciplines.
Deep understanding of Quality Management systems and enterprise information systems.
Proficiency with the Software Development Life Cycle (SDLC) including developing and executing validation activities.
Good understanding of US, Canadian and EU regulatory requirements of Quality Systems.
Experience in Internal Audit, Supplier Audit, and Regulatory Audit processes.
Demonstrated ability to manage a team and provide coaching and feedback.
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization.
Ability to work and excel within a fast paced, dynamic, and constantly changing work environment.
Strong analytical and logical problem-solving skills
Strict attention to detail.
Medical Device industry experience is a plus.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.