Principal Supplier Quality Engineer - Medical Dev – Fremont

General Summary:

• Independently, or as a member of a project team, in conformance with BSC’s Quality Systems, develops, directs, and executes plans for successful support of diverse Supplier Quality Assurance activities.
  
• Demonstrates leadership in Receiving Inspection operations, Supplier Survey and/or audit responsibilities, and new product development operations. Demonstrates a breadth of industry and technical understanding and insight within Supplier and Incoming Quality Assurance.
  
  
  Specific Duties and Responsibilities
  
  
• Consistently generate and implement innovative and unique solutions to complex technical problems. Develops and influences others: as an idea leader, a group leader, an internal consultant, and mentor to more junior staff, etc.
  
  
• Monitor supplier performance, analyze, and take appropriate action.
  
  
• Ability to present key departmental and supplier performance information to the SQA manager, senior management, and outside departments.
  
  
• Provides internal customers and suppliers with robust statistical sampling plans, inspection methodology, and procedures.
  
  
• Senior technical resource for process improvement projects such as alternative measurement/testing methodologies, and parts qualification techniques for reduction in incoming inspection reduction.
  
  
• Independently assist Incoming Quality in resolving internal and external audit findings and observations, non-conformance reports, corrective actions, and system improvements, as needed.
  
  
• Develops Standard Operating Procedures, and IQC documents and modifies existing Inspection documents for the purpose of improving processes. Initiates and approves ECO’s as necessary.
  
  
  
• Active participant in MRB meetings. Review incoming material and/or in-process rejections, determine appropriate actions, and ensure follow through. Evaluation and sign off on NCMR disposition as required.
  
  
• Serve as part of auditing teams and as lead auditor for Supplier Quality, as required.
  
  
• Follow-up responsibility for Supplier Corrective Actions.
  
  
• Member of new product development teams and supplier development as required.
  
  
• In the absence of the departmental manager, may assume daily management responsibilities as requested by the manager.
  
  
• Undertakes special assignments at the direction of the SQA manager.
  
  
• Occasional extensive travel to suppliers as required.
  
  
  
• Performs responsibilities required by the Quality System and other duties as assigned or requested.
  
  
  
  Position Qualifications
  
  Minimum education:Bachelors Degree in Science or Engineering related fields, EE degree preferred, Masters Preferred. ASQ certification is plus (CQE, CQA).
  
  Minimum experience:At least eight years experience in a supplier quality or quality engineering function, 4 years in a medical device environment. Thorough understanding of inspection methods. Expertise in the areas of statistical plans and lot acceptance sampling methodologies. Experience working in a Manufacturing and Development environment. Requires planning and organizational skills in complex technical functions. Ability to work under pressure with multiple priorities. Extensive knowledge of ISO and FDA QSR requirements.
  
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