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Job ID :
49418BR
Location :
US - California - San Jose
:
Job Description
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Position Summary:

With an ownership mindset, The Supplier Quality Engineer (SQE) will demonstrate leadership to drive quality improvements and performance of Thermo Fisher’s global supply base.

The SQE will be responsible for all technical aspects of Supplier Development including managing performance metrics, evaluating/monitoring the suppliers’ Quality Management Systems (FDA CFR Part 820 and ISO 13485 regulations/standards), policies, procedures and controls that ensure that supplied product performance and quality meet Thermo Fisher Scientific requirements, deploying an effective SCAR/CAPA system, and understanding suppliers’ processes through both QMS and detail process auditing.

In addition, the SQE will assist in evaluating incoming materials (inspection technique support, verification/validation activities, disposition of nonconforming product), promote supplier continuous improvement efforts, and support NPI activities for incoming products into the San Jose factory.

Key Duties and Responsibilities:
  • Deliver improved supplier performance over time
  • Communicate engineering changes and ensure supplier readiness for implementation
  • Manage Resolution of Issues through use of Action Trackers, Conference Calls, Supplier Visits, Training, etc.
  • Facilitate supplier activities associated with NPI projects (first article inspection reports, validation, qualification)
  • Lead supplier development activities by conducting reviews and visiting supplier sites
  • Establish and report on quality benchmarks and metrics for measuring efficiencies and effectiveness of all supplier performances that affect Thermo Fisher Scientific products and services
  • Develop initiatives and review metrics to identify cost of poor supplier quality
  • 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
  • Lead and participate in continuous improvement process 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

Minimum Qualifications/Requirements:
  • B.S. degree in engineering or related technical field
  • At least 5 years of 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

Preferred Qualifications:
  • BS in Electrical Engineering
  • Working knowledge in Supply Chain Management
  • Proven track record showing ability to improve supplier performance
  • Experience using statistical tools such as Minitab, QC Calc, etc.
  • Knowledge of RoHS/REACH requirements
  • SAP experience
  • ASQ Certified Quality Engineer
  • Qualified lead auditor certification or equivalent training in ISO or GMP standards


*ING-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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