2150 - 1579 Quality Operations Manager
DeRoyal•New Tazewell, TN
About The Position
Global medical device manufacturer, DeRoyal, is seeking a Quality Operations Manager to lead and enhance quality processes within our manufacturing operations. This role is responsible for ensuring product quality, regulatory compliance, and operational excellence while driving continuous improvement initiatives. The ideal candidate will bring strong leadership, analytical skills, and experience in quality systems within a regulated environment.
Requirements
- Bachelor’s degree or minimum of 8+ years of relevant experience required; or a combination of education and relevant work experience
- Knowledge of FDA regulations and ISO standards
- Strong analytical and communication skills
- Proficiency in Microsoft Office
Responsibilities
- Lead and implement quality control processes across the production lifecycle
- Partner with manufacturing teams to resolve quality issues
- Maintain and improve quality management systems
- Oversee customer complaint investigations and CAPA processes
- Ensure compliance with FDA QSR and ISO 13485 standards
- Lead audit preparation and execution
- Analyze data and present findings to leadership
- Drive continuous improvement initiatives
- Manage customer and vendor quality relationships
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What This Job Offers
Job Type
Full-time
Career Level
Manager
