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Supplier Quality Engineer II - New Product Development

Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: November 18, 2021

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. With its strong focus on employee wellbeing and culture of continued learning and improvement, Edwards is a perfect place to grow and launch your career.. The Critical Care Quality Organization has a current opening for a Supplier Quality Engineer II in Irvine, CA. This engineer will be a key partner to the NPD (New Product Development) project teams in ensuring the supplier fully understands Edwards Lifesciences' expectations and delivers to the same end to end. The NPD team is a community of engineers that is effective in relationship and sensitive to patient and business needs, hence drives the right behavior and mindset. The role provides an excellent opportunity for learning, networking, collaboration, visibility, building relationships with multiple Edwards functions, sites and suppliers.. Responsibilities:. Be a trusted partner by leading the selection, assessment, and qualification of suppliers for NPD projects including supplier audits to ensure that products received from external suppliers conform to pre-established requirements. Drive excellence by defining supplier qualification requirements for components, devices and custom materials for NPD projects to ensure the needs from R&D and Manufacturability are balanced. Foster collaboration with Edwards plants to establish an optimized receiving inspection strategy while promoting inspection at source. Develop Test method validation with guidance from team members.. Build supplier capability and innovation through Edwards supplier excellence initiatives . Identify and implement improvements in products and processes at the suppliers.. Build strong supplier relationships through onsite visits, Edwards supplier relationship management programs, supplier forums and other interactions.. Partner and interact with suppliers; including managing any non-conformances from suppliers as well as handling notification of changes received from the supplier. Lead in the investigation of complex manufacturing product quality and compliance issues (e.g., SCARs (Supplier Corrective Action Reports), CAPAs, non-conformances, audit observations) for all production processes based on engineering principles; analyze results, make recommendations, and develop reports. Initiate and participate in the completion of a Product Risk Assessment for relevant complaints.. 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; OR a Master's Degree in Engineering or Scientific field with no experience (or applicable internship experience). Preferred Qualifications:. Experience with supplier/vendor management and qualification activities with new suppliers, CMOs (Contract Manufacturing Organizations), or OEMs for new products.. Experience with CAPAs, NCRs, Change Notifications, and/or Auditing. Demonstrated experience driving component testing, test method validations, and testing equipment. Utilizing design tools such as SolidWorks (or other similar design tools). Knowledge and understanding of FDA and international regulatory standards (i.e. ISO 13485 & ISO 14971) for medical devices is preferred.. Ability to manage multiple and frequently changing projects and priorities. Highly developed time management, program management, communication, and documentation skills are essential.. Ability to work independently without close supervision.. Understanding of risk management and process qualification.. Demonstrated ability to apply basic statistical quality engineering tools in a supplier environment.. Certified Lead Auditor / ASQ Certified Biomedical Auditor. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.. Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. 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 religious or medical exemption from being vaccinated.

Keywords: Edwards Lifesciences Gruppe, Irvine , Supplier Quality Engineer II - New Product Development, Engineering , Irvine, California

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