Edwards Lifesciences Quality Systems Analyst, Supplier Quality in Irvine, California
Edwards Lifesciences has an opening for a Quality Systems Analyst, Supplier Quality. The Analyst will be responsible to review, analyze, and evaluate business needs to create solutions that support overall business strategies. They will document business requirements, define scope and objectives that drive process development and implementation, and will functions as an integrator between the business users, IT and corporate compliance with both business and technical expertise.
• Support Quality strategic initiatives by working with business representatives to understand, and document the business requirements, processes and workflows developing both written and visual depictions of requirements and process flows. Partner effectively with all levels of the organization to drive results, proactively identify and resolve problems and escalate as required. Work with IT to develop functional specifications and act as Subject Matter Expert for the proposed solutions.
• Lead small scale projects where analysis of situations requires an in-depth evaluation of multiple factors and/or requires an in-depth knowledge of organizational objectives.
• Other incidental duties assigned by Leadership
• Bachelor's Degree in related field and 3 years of experience
• Experience in a quality and/or manufacturing environment in the medical device industry
• Previous project management experience working with related software tools
• Solid computer skills in MS Office Suite
• Good project management skills and related software tools preferred
• Good written and verbal communication skills including negotiating and relationship management skills
• Good problem-solving, organizational, analytical and critical thinking skills
• Solid knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality systems
• Results-oriented, positive “can-do” attitude with demonstration of appropriate urgency and initiative
• Detail oriented, producing high quality work
• Ability to interact professionally with all organizational levels. Strong ability to manage and work with different cultures and nationalities, experience working in complex global environment
• Working experience influencing others to action who are not direct reports
• Ability to manage competing priorities in a fast paced environment, show initiative; be flexible and detail-orientated
• Work is performed independently on small to medium sized projects
• Applies sound judgment when making decisions and communicating with peers and management
• Ability to adapt to new technologies and rapidly changing environment
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.