Edwards Lifesciences Veterans Jobs

Job Information

Edwards Lifesciences Staff, Quality Systems in Irvine, California

Key Responsibilities:

  • Identify, lead and provide business process improvement solutions for Quality Systems, including reviewing and approving changes to procedures, to improve operation, efficiencies, and user experience

  • Lead moderately complex projects from inception through completion, including developing and/or scheduling key milestones, securing and allocating resources, and representing quality management on cross-functional teams

  • Manage all phases of the small to medium quality systems (e.g., CAPA, NCR, Supplier)

  • Review and approve changes to documentation associated with Quality Systems, as well as assessing effectiveness and approving recommendations of others

  • Drive investigations of basic problems, perform robust root cause analysis, develop and implement corrective actions, and establish monitoring plans in collaboration with cross functional SMEs

  • Review and identify actions from metrics

  • Prepare and pre-review data and documents for integrity prior to presentation in internal and external audit activities

  • Provide technical direction to lower level staff

  • Deliver "train-the-trainer" programs

Required Skills:

  • Bachelor's Degree

  • Eight years of experience in Quality Systems (e.g., CAPA Investigations, Root Cause Analysis, Product Risk Assessment, Non-Conformance Handling) Required

Additional Skills:

  • Proven successful project management skills

  • Proven expertise in MS Office Suite

  • Excellent facilitation and presentation skills

  • Experience with Complaint Analysis Preferred

  • Excellent problem-solving, organizational, analytical and critical thinking skills

  • Excellent documentation, communication skills and interpersonal relationship skills including negotiating and relationship management skills

  • Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards

  • Extensive understanding of Edwards’ policies, procedures, and guidelines relevant to quality systems

  • Extensive knowledge and understanding of medical or pharmaceutical regulations as relating to documentation

  • Extensive understanding of medical devices regulations (e.g., FDA (21 CFR Part 820), ISO13485, and ISO 14971)

  • Ability to transfer essential knowledge and mentor other team members on specialized skills

  • Strict attention to detail

  • Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization

  • Ability to manage competing priorities in a fast-paced environment

  • Ability to represent leadership on sections of projects within a specific area interfacing with project managers and quality systems team

  • Ability to consult in a project setting within specific sections

  • Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

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.