Edwards Lifesciences Associate Quality Compliance Auditing & Data Specialist (Corporate Quality) in Irvine, California
The Associate Quality Compliance Auditing Specialist will be part of Corporate Quality and will be responsible for assisting with the global audit process through data review and planning with various Edwards Lifesciences sites and external agencies (e.g. Notified Bodies or other regulators).
Assist in generating metrics, analyzing data, and identifying continuous improvement opportunities for overall auditing system
Compile key information into a presentable form for senior leadership
Assist in planning external audits and coordinating with external agencies (e.g. Notified Bodies or other regulators)
Collaborate and communicate with Edwards Lifesciences sites globally to ensure data within the electronic audit system (EQMS) is complete and accurate
Provide input and assist with projects, based on understanding of international standards and regulations, for business unit and/or corporate quality initiatives including special projects, such as designing and/or recommending systems, procedures, etc.
Assist team members in moderately complex assessments to ensure conformance with applicable regulations and EW policies and procedures.
Other duties assigned by leadership
Required Qualifications :
- Bachelor's Degree
Preferred Qualifications :
Experience in the medical device industry or a similarly regulated environment
1 year of Quality Compliance experience
Experience with data analysis and reviewing statistical trends
Knowledge and understanding of diverse and applicable regulations and standards relevant to medical devices (e.g., 21 CFR Part 820, ISO 13485, EU MDD, EU MDR)
Experience in an electronic quality management system (e.g. TrackWise, Reliance, Pilgrim, etc.)
Ability to manage multiple projects
Proven expertise in Microsoft Office Suite including Outlook, SharePoint, Teams, Word, PowerPoint, and Excel
Good written and verbal communication skills and interpersonal relationship skills
Good problem-solving and critical thinking skills
Strict attention to detail
Ability to work in a team environment, including immediate supervisor and other team members in the section or group
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast-paced 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.