Edwards Lifesciences Supplier Quality Analyst in Irvine, California
The Supplier Quality Analyst will support THV Supplier Quality - New Product Development in the approval, qualification and control of suppliers and purchased goods. This individual will facilitate compliance to applicable internal and external requirements. You will work in a fast paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success. This role will work in close partnership with Quality, R&D, Operations, Sourcing, and RA.
Evaluate and analyze moderately complex technical information and data related to quality indicators and recommend course corrections. Draft presentations and present summaries of trends, potential root causes, and recommended course corrections
Draft updates to Quality procedures and conduct reviews to finalize procedures
Coordinate document, drawing and receiving router changes
Develop technical justifications and other content for Engineering Change Request (ECR) submissions
Maintain and update the Approved Supplier List (ASL), including: Initiating SARs, coordinating with engineers, managing project priorities, and reviewing content for accuracy
Conducting monthly and quarterly Quality management metrics
Compile data and generate reports for Supplier Quality Engineering and other internal customers
Identify root cause and suggest corrective actions in initial non-conformance investigations
Develop and present training materials for quality system related processes
Lead small scale projects where analysis of situations requires an in-depth evaluation of multiple factors and/or requires knowledge of organizational objectives. Drive to resolve these issues completely and with speed by leveraging your network of key contacts within and outside your own area of expertise.
Other duties assigned by Management, including representing the department in corporate level initiatives.
Basic / Minimum Requirements:
Bachelor's Degree or equivalent in related field
Three (3) years years of experience in supplier quality, change controls, document controls, change management systems, and/or quality management systems
Experience working within a regulated environment
Experience working in these specific regulated environments: medical device, pharma, biotech, aerospace, automotive, or food industries
Good knowledge and familiarity with Good Manufacturing Practices (GMP)
Good computer skills in MS Office Suite
Previous experience in change control or document control preferred
Experience with change management systems preferred
Good written and verbal communication skills including negotiating and relationship management skills
Fundamental project management skills a plus
Full knowledge of Good Documentation Practices (GDP)
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.