A global medical technology company based in Irvine, CA are searching for an accomplished Senior Supplier Quality Engineer to join their growing team! Here, you will be a key support for their New Product Development (NPD) teams in qualifying critical materials and suppliers in support of launching innovative medical devices. This fast-paced role will work closely with R&D, Quality, Operations, Sourcing and Receiving Inspection. This role will be based onsite in Irvine, CA and offers an hourly range of $55-59.
Some Key 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
- Ensure validation methods of critical suppliers and incoming quality control are aligned with international standards, global regulations, and Industry best practices.
- Establish an optimized receiving inspection strategy at Edwards Plants while promoting inspection at source.
- Lead the efforts to ensure optimization of complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement.
Some Key Requirements:
- Bachelor's degree in Engineering or Scientific field plus a minimum of 6 years of experience in either Supplier Quality, Manufacturing, New Product Development/Improvement, or Quality engineering functions required (or Master's degree in Engineering or Scientific field with minimum of 4 years of referenced experience)
- 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) In-depth understanding and experience with risk management for validation qualifications (e.g. equipment or process OQ/PQs).
- Demonstrated ability to apply basic statistical quality engineering tools in a manufacturing environment such as Gage R&Rs, control charting, or statistical process controls
- Certified Lead Auditor / ASQ Certified Biomedical Auditor
- Six Sigma Green or Black Belt Certified
If you feel like you are the right person for the role, please apply with a recent resume!
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