Principal Supplier Quality Engineer (Onsite) Request ID: Req-23932 Location: USA, California, Irvine

Company: Edwards Lifesciences
Location: Irvine
Posted on: May 21, 2023

Job Description:

At Edwards Lifesciences our continued mission is to be reliable, agile, innovative, and patient-focused in providing the highest quality, industry-leading products and solutions to our customers. Join a diverse team of passionate professional with a Patients first work culture in a rapidly growing organization. Edwards is a perfect place to grow and launch your career, with our strong focus on employee well-being and a culture of continued learning and improvement.Edwards Lifesciences has a Principal Supplier Quality Engineer opening within our Corporate Quality organization supporting Advanced Technology (AT). This role will support the newest design and development teams in qualifying critical materials and suppliers in support of launching the newest life-saving medical devices. This is a fast-paced and dynamic role, where taking initiative and collaborating cross-functionally is critical for success. The Principal Supplier Quality Engineer will apply knowledge of quality engineering principles to optimize product development, supplier development, and operations for sourced materials.Job Function:

• Establish and execute supplied part qualifications.
• Align supplier part release with Edwards part acceptance ensuring compliance and driving operational efficiencies.
• Establish appropriate process controls at the supplier through receipt of materials at Edwards.
• Develop technical content of risk management files.
• Use SIX Sigma, LEAN methods, & Design for Manufacturing principles is support of product scale up and transfer to manufacturing locations.
• Lead efforts to resolve issues and drive innovative solutions.
• Develop training & work instructions to ensure seamless new product knowledge transfer from R&D to operations.
• Expected to report out to upper management on project deliverables and timelines.
• Responsible for ensuring compliance with all Federal, State, local, and company regulations, policies, and procedures.
• Serves as best practice/quality resource within own discipline or as technical expert on functional or cross-functional teams or projects.
• Perform other responsibilities as assigned.Required Education & Qualifications:
  • Bachelor's degree in engineering or scientific field with at least 6 years of relevant experience; OR Master's degree in engineering or scientific field with at least 5 years of relevant experience
  • Knowledge and understanding of FDA and international regulatory standards for medical devices (i.e., ISO 13485 & ISO 14971) is required.
  • Demonstrated experience with Supplier Quality / Vendor Management
  • Demonstrated Project Management experience
  • Ability to travel domestically and internationally up to 30%Preferred Qualifications:
    • Green Belt / Black Belt certified preferred.
    • Demonstrated experience overseeing and managing audits, SCARs, NCRs, and coordinating notification of change with suppliers.
    • Ability to conduct effective root cause investigations.
    • Strong geometric dimensioning and tolerancing (GD&D) knowledge relative to print specifications.
    • Advanced understanding of verification & validation, statistical techniques, and risk management.
    • Well-versed in statistical tools such as control charting & statistical process controls.
    • Ability to develop statistically appropriate inspection plans that address critical to quality features & risk analysis.
    • In-depth understanding and experience with risk management for validation / qualifications (e.g. equipment &/or process OQ/PQs).
    • Strong understanding of manufacturing processes (ex. injection molding, extrusion, machining, etc.)
    • Strong communication and organizational skills to effectively manage and gain buy-in from internal & external stakeholders.
    • Ability to translate technical information to all levels of the organization.
    • Work is performed independently while exercising considerable latitude in making significant decisions.
    • Must be able to work in a team environment.Edwards is committed to complying with the requirements and guidance to ensure protection of patients and healthcare providers. As such, all healthcare interaction positions require COVID-19 vaccination. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid exemption from being vaccinated.Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.ForCalifornia, the base pay range for this position is $106,000 to $151,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Keywords: Edwards Lifesciences, Irvine , Principal Supplier Quality Engineer (Onsite) Request ID: Req-23932 Location: USA, California, Irvine, Engineering , Irvine, California