Tempus is seeking a Senior Manager in Quality Engineering to enhance product quality in the healthcare technology space, focusing on postmarket surveillance and regulatory compliance.
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Skills
Quality Management Systems (QMS)
FDA regulations
ISO standards compliance
Data analysis
Regulatory reporting
Responsibilities
Oversee postmarket surveillance activities and complaint management
Create and maintain procedures for postmarket processes
Manage regulatory reporting of adverse events
Analyze trends in quality metrics and product improvements
Provide training on complaint handling processes
Collaborate with cross-functional teams on complaint investigations
Education
B.S. in Biology or related field
M.S. in Biology or related field (preferred)
Benefits
Health insurance
401(k) plan
Flexible working hours
Professional development opportunities
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