Edwards Lifesciences Quality Analyst – Project Management Support (Corporate Quality) in Irvine, California
This Quality Analyst position will support the Sr. Manager, Quality and partner with the Global Labeling team at implementing a consistent approach to Quality System integration across labeling activities for all of Edwards Lifesciences’ operating sites. This role will partner with the Global Labeling organization to implement strategies from end-to-end labeling processes. In addition, this role will partner with Edwards’ 3PLs and manufacturing sites regarding labeling process compliance and performance that continuously meets evolving compliance and productivity needs.
Essential Job Functions:
Support process improvement roadmaps (projects and Kaizens)
Establish relationships with the labeling function’s stakeholders
Support cross-functional teams and partnering with project managers to implement strategic projects in support of Edwards strategies
Support global initiatives including system implementations and process changes in Labeling to comply with industry standards and global Regulatory requirements, including, but not limited to, scoping requirements
Support QSS (Quality System Simplification) Labeling Suite. Review and approve Labeling processes procedures, instructions and other documents providing guidance in order to make them compliant with ISO 13485, CFR 820, EU MDR and other regulations worldwide.
Work with global sites and IT to define and maintain Global Standards (incl. assets, labels, systems)
Work with IT to define the new systems/solutions and oversee the completion, accuracy and testing
Functionally support Quality Assurance programs/projects related to Global Labeling in partnership with the Quality leaders in the regions/manufacturing to ensure milestones and deliverables are met and Quality processes and standards are conformed to established standards and Regulatory requirements
Responsible for supporting the usage of lean business tools and mindset to Quality systems within Global Labeling
Continue to support the development of tools to enable monitoring of Quality standards in the Print and Apply Centers Worldwide and implement projects/initiatives to continuously improve the Quality standards
Minimum Education & Qualifications:
Bachelor’s degree in Engineering/Science discipline
Minimum 3 years of experience with quality systems
Regulated industry experience
Medical device, pharma, or biotech industry experience
Experience with Quality Management Systems, specifically CAPAs, Non-Conformances, and Validations
Understanding of interdependencies of Labeling Technology and Solutions is beneficial
Combined Labeling Processes and Quality background is beneficial
Experience providing project management support for medium to large complex projects
Experience with project management methodologies/tools such as Lean, Six Sigma, PMBOK, DMAIC, MS-Project, Visio, or Primavera, etc
Lean/Six Sigma certification is a strong plus
Able to work effectively with individuals internally and externally to Edwards (at all levels and widely-varied disciplines), including strong skills in negotiation and influence is beneficial
Results focus, attention to detail, process-oriented
Strong analytical skills
Problem-solving skills and ability to help others organize problem-solving; and comfortable managing ambiguity
Good communication & presentation skills
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 15,000 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.