Orange County Metro Area, CA 92614 US
R&D Partners is seeking to hire a Sr Engr in Irvine, CA.
Benefits of this role:
Benefits + 401k
Your main responsibilities as a Sr Engr:
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 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.
What we are looking for in a Sr Engr:
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.
Why Choose R&D Partners?
Refer a Friend bonus
$47.33- $59.17 (Dependent on Experience)
R&D Partners is a specialist employment agency and recruitment business providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal opportunity employer.