Edwards Lifesciences Supplier Quality Analyst in Irvine, California
The Supplier Quality Systems Analyst will be responsible for oversight & management of QMS database for supplier quality globally, including supplier corrective action, supplier change notifications, supplier quality procedure suite related CAPAs (Corrective and Preventive Actions) and supplier files. Will be responsible for reporting of metrics from the database and support of system changes and/or validations. In addition, will be responsible for oversight of Supplier File Maintenance requirements.
Additional Essential Job Functions :
Subject Matter Expert on software system used for management of supplier files and approval of parts & services globally
Participate in annual supplier file review process coordinating across all Edwards sites to update Quality Agreements where needed
Manage Global Supplier Quality Procedure Suite CAPAs.
Partner with Legal to manage Quality Agreements within Edwards’ Contract Lifecycle Management (ECLM) system
Provide first-level help desk support to users, including process coaching and troubleshooting system issues, (e.g., system access, systems response) before escalating to IT if needed.
Identify and recommend opportunities for improvement related to current business processes and systems (i.e. new metrics, metric optimization, data verification, new data repositories and/or extraction methods)
Meet with users to confirm business needs and develop reporting specifications and functionality, as well recommending other functionality.
Provide first level assessment of records, documentation, and electronic submissions prior to routing for approvals
Final reviewer of change packages for completeness prior to closure within the database.
Management of supplier notification of changes assuring proper dissemination of information.
Other incidental duties assigned by Leadership
Minimum Education & Qualifications:
Bachelor's Degree plus a minimum of 3 years of experience in supplier quality, quality systems, quality assurance, or manufacturing
Experience owning and/or executing tasks related to CAPAs
Preferred Qualifications :
Medical Device industry experience
Experience supporting enterprise level applications or demonstrated equivalent competency, with strong knowledge of: Data analytics systems (e.g. Qlikview); ERP (e.g. JDE or SAP); PLM (e.g. TeamCenter, Agile, or Ignite); and/or QMS (e.g. Pilgrim, TrackWise, or ETQ)
Knowledge of FDA regulations
Solid computer skills in MS Office Suite
Good written and verbal communication skills including negotiating and relationship management skills a must
Good problem-solving, organizational, analytical, and critical thinking skills
Ability to adapt to new technologies and rapidly changing environment
Results-oriented, positive “can-do” attitude with demonstration of appropriate urgency and initiative
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
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.