Education:
• A minimum B.Sc. degree in Engineering, Biology, Chemistry, or related science. M.S. or M.B.A. is a plus. Six Sigma certification is also a plus.
Experience:
• Must have a minimum of 5 years at a management level leading a Quality Assurance and/or Quality Operation groups in a GMP/ISO regulated industry (i.e. Medical Devices and Diagnostics preferred).
• Quality engineering experience with manufacturing process improvements is a plus.
• Experience with continuous improvement tools (e.g., Six Sigma, Lean, SPC, etc.)
• Experience in building global quality systems, and building a strong global team.
• Excellent working knowledge of US, and EU regulations.
• Direct experience in interacting with US and EU regulatory authorities or ISO auditors.
• Global/International experience and background
• Experience with audits from large medical device, diagnostics &/or pharmaceutical customers.
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