Senior Quality Manager
Job Summary
To drive quality technology strategy and digital transformation, the full-time Senior Quality Manager will manage global quality systems, ensure compliance with FDA regulations, and lead a team in implementing innovative quality solutions in a remote environment.
Key responsibilities
- Define and execute the quality management system (QMS) technology strategy, aligning stakeholders on scalable solutions
- Provide technical oversight and leadership for regulated quality processes, ensuring compliance and audit readiness
- Lead the adoption of digital quality solutions and training initiatives to enhance user experience and operational efficiency
Required qualifications
- Bachelor's degree in Engineering, Life Sciences, Information Systems, or a related technical field
- 8+ years of experience in Quality, IT, Operations, or related functions within an FDA regulated environment
- 3+ years of supervisory or leadership experience
- Experience with technologies used in FDA-regulated environments, including QMS and MES
- Strong knowledge of medical device quality system requirements and lifecycle governance
Complete Job Description
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