Engineer, Supplier Quality III

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Supplier Quality Engineer III

Position Objective:

As a Supplier Quality Engineer III, you will support the organization across the Biological and Chemical commodity ensuring 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. The Staff Supplier Quality Engineer 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
• Actively participate in strategic supplier development based on risks identified through Supply Risk Mitigation team

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:

• Min 5 years experience in 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
• Power BI and Data Analytic skills required

Working Conditions / Travel Requirements:

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