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Job ID :
44988BR
Location :
US - California - San Jose
:
Job Description

Key Responsibilities:

  • Works with R&D in conjunction with supplier on New Product Introduction (NPI) projects.
  • Leads supplier development activities by conducting reviews and visiting supplier sites focusing on developing and implementing improvements/modes of control within the supplier processes to minimize non-conformances.
  • Establishes and reports on quality benchmarks and metrics for measuring efficiencies and effectiveness of all supplier performances that affect Thermo Fisher Scientific products and services.
  • Develops initiatives and reviews metrics to identify cost of poor supplier quality. Using various data collection methodologies, will measure, analyze and improve Supplier performance and reduce supplier non-conformances.
  • Ensure Quality Assurance for existing suppliers including source inspection, review of incoming raw materials (as required), and change control process management.
  • Drive continuous improvement process (CIP) activities such as PPI, Kaizen, Lean
  • Review supplier manufacturing process and collaborate with them on process improvement opportunities
  • Perform and maintain product/process risk analysis and ensure mitigations are implemented and effective (Supplier Process FMEA)
  • Execute Lead Auditor function for assigned suppliers based on ISO 9001, 13485 and 21CFR820 clauses
  • Ownership/leadership mindset

Requirements:

  • B.S. degree in engineering or related technical field, or equivalent experience
  • 0-5 year’s experience with manufacturing, assembly and test
  • Experience with manufacturing support of electromechanical devices
  • Experience in an ISO/FDA regulated environment, including manufacturing support, and process improvement is required.
  • Experience with New Product Development, including verification, validation and FMEA
  • Proficient in use of statistical analysis and methods such as Lean, 5 Why’s, Pareto Analysis, SPC, FMEA, Six Sigma, etc.
  • Must have excellent written and verbal communication skills with ability to clearly articulate requirements
  • Experience using MS Office suite.
  • Ability to travel up to 25% domestically and internationally

Preferential Factors:

  • BS in Electrical Engineering
  • Supply Chain Knowledge
  • Experience using statistical tools such as Minitab, QC Calc, etc.
  • Knowledge of RoHS requirements.
  • SAP experience a plus
  • ASQ Certified Quality Engineer
  • Qualified lead auditor certification or equivalent training in ISO or GMP standards.
*IND-AIG



Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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