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Supplier Quality Engineer II (Transcatheter Heart Valves)

Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: February 18, 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. USA - California - Irvine Role Description: The Supplier Quality Engineer II 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, Operations, Quality, Sourcing, and Regulatory Affairs.

Job Function:

  • Responsible for ensuring compliance with all Federal, State, local, and company regulations, policies, and procedures.
  • Works with suppliers to ensure quality system and supplied product requirements are understood and successfully met.--
  • Responsible for helping define supplier qualification requirements for OEM and custom materials and devices.
  • Ensures validation methods of critical suppliers and incoming quality control are aligned with device risk, internal requirements, international standards, global regulations, and Industry best practices.
  • Supports completion of Design History File requirements applicable to supplied components, subassemblies, devices, and services.
  • Supports risk management activities with suppliers.
  • Executes test method validation activities for receiving inspection and/or supplier final release.
  • Knowledge of CAPA elements is preferred.
  • Assesses non-conformances and leads closure of SCARs as needed.
    -- Required Education / Qualifications:
    • Bachelor's degree in Engineering or Scientific field with at least 2 years of experience with supplier quality, manufacturing, or quality engineering functions
    • Highly regulated industry experience Preferred Qualifications:
      • Experience with supplier quality engineering activities, including external supplier vendor audits
      • Effective problem-solving techniques and experience with technical tools (i.e. Root Cause Analysis, dFMEA process, Gage R&R, etc.)
      • Proficient understanding of Design Controls, test method development & validation, and risk management.
      • Conduct effective root cause investigations; assessment of corrective action strategies; and effectiveness as applied to NCRs and SCARs
      • Experience with class II and class III medical devices
      • Medical device, pharma, biotech or other regulated industry experience
      • Demonstrated ability to apply statistical quality engineering tools
      • Ability to read and interpret drawings
      • Knowledge and understanding of FDA and international regulatory standards for medical devices is preferred.
      • Ability to manage multiple and frequently changing projects and priorities.
      • Ability to work independently without close supervision
      • Effective communication and conflict resolution skills
      • Highly developed time management, communication, and documentation skills
      • Strong communication and organizational skills to effectively manage and get results with external suppliers
      • Six Sigma Black Belt/LEAN Manufacturing experience
      • ASQ Certified Quality Engineer or ASQ/BSI Certified Quality Auditor
      • Domestic and international travel up to 25% (post-COVID)-- E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. Posted 3 Days Ago Full time Req-6240 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 , Supplier Quality Engineer II (Transcatheter Heart Valves), Engineering , Irvine, California

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