Manager, Value Stream Quality Engineering - Medical Devices
On-site · Elkton, Maryland, United States
Job Summary
Lead a team of Quality Engineers across assigned value streams to manage all aspects of Quality Engineering, including production support, nonconformance investigations, and yield monitoring. Drive process improvements using Six Sigma, LEAN, and Kaizen methodologies and partner with operations leaders to embed a culture of quality. Maintain robust compliance with FDA, ISO, and international medical device regulations. Requires strong data-analysis skills (Excel, Minitab, JMP, PowerBI) and experience in medical device manufacturing or other highly regulated industries. Six Sigma or LEAN certification preferred. This role emphasizes leadership in quality systems within a global medical device organization and impact on patient safety and product reliability.
Required Qualifications
- Experience leading Quality Engineering teams in medical device manufacturing or highly regulated industries
- Strong understanding of quality sciences and data analysis tools
- Familiarity with FDA, ISO, and international medical device regulations
- Knowledge of Six Sigma or LEAN methodologies (certification preferred)
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