Senior Quality Systems Analyst (Corporate Quality)

Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: April 5, 2021

Job Description:

We have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience. Senior Quality Systems Analyst (Corporate Quality) USA - California - Irvine The Senior Quality Systems Analyst will ensure that Edwards has the key quality information necessary for regulatory compliance.

Key Responsibilities:

• 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 customers
  Identify 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.
    • 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 E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. Full time Req-7160 About Us 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.

Keywords: Edwards Lifesciences Gruppe, Irvine , Senior Quality Systems Analyst (Corporate Quality), Professions , Irvine, California