Edwards Lifesciences Senior Quality Systems Analyst (Corporate Quality) in Irvine, California
The Senior Quality Systems Analyst will ensure that Edwards has the key quality information necessary for regulatory compliance.
Lead in the evaluation and analysis of complex technical information and data related to production quality indicators, identifying trends and driving factors, and recommending course corrections.
Draft presentations and present summaries of trends, potential root causes, and recommended course corrections
Draft complex updates to Quality procedures (e.g., inspection improvement initiatives), and conduct reviews to finalize procedures
Contribute process knowledge to, develop and lead the implementation of proposed modifications to resolve open issues on Quality, Engineering, and Manufacturing projects, as part of cross-functional technical groups
Manage projects to improve the Quality System while collaborating with cross-functional groups globally.
Develop technical justifications and other content for Engineering Change Requests (ECRs) submissions
Compile data and generate reports for Engineering and other internal customersIdentify root cause and suggest corrective actions in initial non-conformance investigations
Develop and present training materials for quality system related processes
Other duties assigned by Leadership; support corporate level project management, including representing the department in corporate level initiatives; and execute software validations impacting quality systems.
Required Qualifications :
Bachelor's Degree plus a minimum of 5 years of quality experience; or Master’s degree with a minimum of 3 years of quality experience
Experience with project management methodologies; or leading/supporting mid to large scale quality related projects
Medical Device, Pharmaceutical, and/or Biotech industry experience
Preferred Qualifications :
Experience with Quality Management Systems and Regulations (e.g. 21 CFR Part 820, MDD, ISO 13485, and/or EU MDR)
Experience with preparation, management of external audits and performing internal audits
Computerized systems validation experience and writing validation protocols is a strong plus
Experience with project management methodologies/tools such as Lean, Six Sigma, PMBOK, DMAIC, MS-Project, Visio, or Primavera, etc.
Proven expertise in MS Office Suite
Excellent written and verbal communication skills including negotiating and relationship management skills
Ability to manage competing priorities in a fast-paced environment
Ability to interact with senior internal and external personnel on significant matters often requiring coordination within and between organizations
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.