Staff Engineer, Supplier Quality – Transcatheter Mitral and Tricuspid Therapies

  • Edwards Lifesciences
  • Irvine, CA, USA
  • Jul 20, 2020
Full time Health Care

Job Description

The Staff Supplier Quality Engineer will directly support the design and development teams in qualifying critical materials and suppliers in support of launching innovative & life-saving medical devices.  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 R&D, Marketing, Operations, Sourcing, and RA.

Job Function:

  • Lead part and supplier qualification activities in compliance with Edwards’s QMS requirements
  • Support component specification development, identification of critical features, development of inspection methods and plans, test method validation, and component capability assessments
  • Support risk management activities, including the development and implementation of FMEAs, process control plans, and quality agreements at suppliers
  • Support suppliers in the development, approval and execution of process validation protocols and reports for critical processes
  • Perform audits of Quality Systems and Processes at suppliers of materials, components, sub-assemblies, and services.
  • Analyze and support the effective resolution of complex manufacturing and compliance issues at suppliers resulting from audit observations, incoming/process non-conformance reports, and customer complaints
  • Utilize statistical techniques and six sigma tools to analyze processes and drive continuous improvement activities
  • Collect and analyze Quality metrics relating to Supplier Quality
  • Guide quality engineers as a subject matter expert in technical areas
  • Communicate supplier quality risks to management or internal teams during reviews and project meetings, and identify solutions to mitigate risks.
  • Support process and system improvement projects as assigned by manager


Required Education/Skills/Experience:

  • Bachelor degree in technical or science field with a minimum 5 years’ experience or master’s degree plus 4 years’ experience in medical device manufacturing.
  • Knowledge and understanding of FDA and international regulatory standards for medical devices is required.
  • This role involves management of multiple and frequently changing projects and priorities. Highly developed time management, communication, and documentation skills are required.
  • Excellent documentation and communication skills and interpersonal/intercultural relationship skills including influencing, negotiating and relationship management skills.
  • Ability to work independently without close supervision.
  • Advanced understanding of V&V, statistical techniques, test method development, and risk management.
  • Demonstrated ability to apply statistical quality engineering tools in a supplier environment is required.
  • Ability to read and interpret drawings.
  • Serves as best practice/quality resource within own discipline or as technical expert on functional or cross-functional teams or projects.
  • ASQ Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA), Certified Quality Engineer (CQE), or related quality certifications preferred.
  • General understanding of plastic manufacturing or metal fabrication methods are a plus.
  • Experience with Class III medical devices required, and experience with implantable devices preferred

Domestic and international travel is required. Expected 25% travel.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.