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Quality Assurance Specialist, Senior
2 months ago
Job Summary:
Tempus is seeking a highly skilled Senior Quality Assurance Specialist to support quality activities related to incidents and issues, including deviations, nonconformances (NC), and corrective and preventive actions (CAPA) in accordance with FDA QSR (Quality System Regulation), ISO 13485, and other applicable global regulations.
Key Responsibilities:
- Incident Management: Responsible for processing and managing issues/incidents that include deviations, NCs, and CAPAs, ensuring compliance to FDA 21 CFR 820, ISO 13485, CAP/CLIA, and other applicable quality system regulations and standards.
- Process Improvement: Participate in process improvements to the issue/incident reporting framework by identifying areas for improvement, simplification, and standardization, ensuring that various systems are streamlined and aligned.
- Regulatory Compliance: Collaborate with Regulatory on appropriate health authority reporting, as necessary.
- NC/CAPA Activities: Assist in NC/CAPA activities, including investigations, root cause analysis, effectiveness verification, and closure by establishing cross-functional relationships and collaborations with functional owners.
- Issue Resolution: Drive ownership of issues/incidents to lead to final resolution and closure by providing training and guidance to owners.
- Departmental Goals: Responsible for assisting in activities to ensure departmental goals for deviations, NC, and CAPA processes are achieved.
- Trend Analysis: Identify trends and provide metrics to drive root cause analysis and corrective actions to prevent the recurrence of quality issues.
- Audit Support: Participate as a NC and CAPA subject matter expert during internal and external audits.
Requirements:
- Education: Bachelor's Degree in Engineering or Science field.
- Experience: 3+ years of QA experience in a clinical laboratory/medical device/Diagnostic company, working on deviations, Nonconformances, and CAPA processes.
- Regulatory Knowledge: 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).
- QA Experience: QA experience in a clinical molecular testing laboratory (LDTs) is required.
- Communication Skills: Strong communication (written and verbal), influencing, negotiating, and collaboration skills.
- Problem-Solving: Ability to work through complex issues and differences in a creative, constructive, and diplomatic manner.
- Leadership: Ability to demonstrate leadership in helping improve quality processes and create efficiencies for business needs.
- Independence: Ability and willingness to work independently and take initiative to ensure timely action on issues.
