BCD Supplier Quality Engineer III

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work! And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make meaningful contributions to the world.

Position Objective:

As a BCD Supplier Quality Engineer III, you will support the sites within BCD (Biological and Chemicals Division) by ensuring supplier compliance, reduction of cost of poor quality, identifying and driving cost reductions, focusing on supplier continuous improvements, and reducing risk in our supply chain. Will also support team to solve raw material issues while working to grow the supply base capabilities. Will work closely with a multi-functional team to quickly mitigate and deploy decisive actions. Will manage Supplier Quality processes in compliance with ISO 9001/13485, FDA, GMP and other external requirements. This role may lead or represent strategic projects or initiatives as necessary.

Essential Functions:

A leader of processes to improve supplier performance, drive down cost of poor quality, ability to identify/leverage analytics and data for business problem solving and ability to see issues from multiple viewpoints and understand differing needs of partners. Act as the liaison for suppliers, suggest quality and process improvements while collaborating with internal subject matter experts. Manage Supplier Quality procedures and processes in compliance with ISO, FDA, GMP and other external requirements.

Key Responsibilities:

Manage Supplier Issues

• Collaborate with global and local functions to define actions and priorities for supplier related quality issues
• Be a champion of problem solving /root cause analysis activities with suppliers and customers to eliminate recurrence of non‐conformances
• Work actively with Global Supplier Quality in order to ensure accurate data, act on identified risks, and plan audits for internal and external suppliers and OEMs.
  
  

Other Requirements

• Proficient in the development and execution of quality metrics
• Project planning and proficient in the use of Excel, Word, Access, and quality management software
  
  

Education Requirements:

• B.S. Engineering/Operations Management, Biological Sciences or equivalent
• Quality lead auditor training certificate preferred
  
  

Experience Requirements:

• Proven experience in Quality and/or Supplier Management
• Solid experience with ISO 13485 required and 21 CFR Part 820 preferred
• Excellent oral and written communication skills in English language required
• Solid understanding of six sigma tools such as 8D, FMEA, DMAIC, Value Stream Map and Pareto Analysis preferred
• Knowledge of statistical tools such as SPC, statistical sampling, DOE preferred
  
  

Working Conditions / Travel Requirements:

• Visits to factories wearing PPE, including cleanroom PPE
• Travel required up to 25% (domestic/international)