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 Quality Assurance Specialist plays an integral role in supporting quality activities related to incidents and issues, including deviation, nonconformances (NC) and corrective and preventive actions (CAPA) in accordance with FDA QSR (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. Other duties may be assigned.
- Responsible for processing and managing issues/incidents that include deviations, NCs, and CAPAs, as well as ensuring compliance to FDA 21 CFR 820, ISO 13485, CAP/CLIA and other applicable quality system regulations and standards.
- Participate in process improvements to the issue/incident reporting framework by helping identify 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.
- Assist in NC/CAPA activities, including investigations, root cause analysis, effectiveness verification, and closure by establishing cross-functional relationships and collaborations with functional owners.
- Drive ownership of issues/incidents to lead to final resolution and closure by providing training and guidance to owners.
- Responsible for assisting in activities to ensure departmental goals for deviations, NC and CAPA processes are achieved.
- Identify trends and provide metrics to drive root cause analysis and corrective actions to prevent the recurrence of quality issues
- Participate if needed as a NC and CAPA subject matter expert during internal and external audits.
Required Education & Experience:
- Bachelor’s Degree in Engineering or Science field.
- 2+ years of Quality Assurance or Quality Engineering experience in a clinical laboratory/medical device/Diagnostic company, with a minimum of 2 years of NC and CAPA experience in the FDA regulated industry - medical devices or IVDs.
- Working knowledge of medical device / in vitro diagnostic regulations and QMS (e.g., FDA 21 CFR 820, ISO 13485, IVDD, and other applicable quality and regulatory standards).
- Strong communication (written and verbal), influencing, negotiating and collaboration skills.
- Ability to work through complex issues and differences in a creative, constructive, and diplomatic manner.
- Must be self motivated and have the ability to manage multiple tasks with limited supervision.
- Ability to demonstrate leadership in helping improve quality processes and create efficiencies for business needs.
- Ability and willingness to work independently and take initiative to ensure timely action on issues.
- This will be an on-site position supporting weekend/holiday shifts.
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