Remote Senior Manager Quality Assurance

Summary

Join Tempus as a Senior Manager, Quality Assurance to lead quality activities and strategies related to incidents and issues, ensuring compliance with FDA regulations and other applicable standards.

Requirements

• Bachelor’s Degree in Engineering or Science field
• 10+ years of Quality Engineering or Quality Assurance experience in a clinical laboratory/medical device/diagnostic company, with working knowledge on nonconformance and CAPA processes
• Mandatory working knowledge of medical device / in vitro diagnostic regulations (e.g., FDA 21 CFR 820, ISO 13485, IVDD, and other applicable quality and regulatory standards)
• Strong communication (written and verbal), leadership, influencing & negotiating and collaboration skills
• Ability to work through complex issues and differences in a creative, constructive, and diplomatic manner
• Ability to manage multiple tasks with limited supervision
• Ability to demonstrate leadership in helping improve quality processes and create efficiencies for business needs
• Strong project management expertise and ability to focus on execution of strategic decisions while balancing conflicting priorities

Responsibilities

• Responsible for overseeing the issue/incident framework that includes the NC and CAPA systems, ensuring compliance to FDA 21 CFR 820, ISO 13485, CAP/CLIA and other applicable quality system regulations and standards
• Oversee the activities and development of reporting staff with their day to day issue management activities, including but not limited to NC/CAPA administration and maintaining high-quality standards for records and data
• Lead process improvements to the issue/incident reporting framework by identifying areas for improvement, simplification, and standardization, ensuring that the various systems are streamlined and aligned
• Collaborate with Regulatory on appropriate health authority reporting, as necessary
• Drive NC and CAPA activities, partnering with subject matter experts (SMEs) to conduct investigations, root cause analysis, effectiveness verification, and closure
• Establish cross-functional relationships and collaborations with NC and CAPA owners
• Develop and maintain issue management procedures and documentation to ensure adherence to regulations
• Responsible for coordinating and implementing activities to ensure departmental goals for issue management processes are achieved
• Identify trends and provide metrics to drive root cause analysis and corrective actions to prevent the recurrence of quality issues
• Establish and generate issue management metrics for management reviews to drive continuous improvement
• Lead and participate as issue management subject matter expert during internal and external audits
• Support other duties as assigned

Benefits

This position may be remote