Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
The Senior Manager, Quality Assurance plays an integral role in leading quality activities and strategies related to incidents and issues (e.g., Issue Management), including nonconformances (NC) and corrective and preventive actions (CAPA) in accordance with the FDA Quality System Regulation, ISO 13485, and other applicable global regulations. This individual also supports the QMS activities that comply with CLIA/CAP requirements for the clinical laboratories.
Responsibilities include the following:
- 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.
Qualifications
- 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.
- This position may be remote.
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