Tempus
Senior Quality Assurance Specialist, Nonconformance and CAPA
Tempus, Chicago, Illinois, United States, 60290
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 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 deviations, NCs, and CAPAs compliance with 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.Facilitate 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 issuesParticipate if needed as a NC and CAPA subject matter expert during internal and external audits.Lead and/or support other duties as assigned.Required Education and Experience:
Bachelor's Degree in Engineering or Science field.Mandatory 3+ years of QA experience in a medical device/Diagnostic company working on deviations, Nonconformances and CAPA processes.Working knowledge of NC and CAPA processes in accordance with medical device / in vitro diagnostic regulations (e.g., FDA 21 CFR 820, ISO 13485, IVDR, 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.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.
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We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote roles- Tempus reasonably believes that criminal history may have a direct, adverse and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment: engaging positively with customers and other employees; accessing confidential information, including intellectual property, trade secrets, and protected health information; and appropriately handling such information in accordance with legal and ethical standards. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
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 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 deviations, NCs, and CAPAs compliance with 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.Facilitate 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 issuesParticipate if needed as a NC and CAPA subject matter expert during internal and external audits.Lead and/or support other duties as assigned.Required Education and Experience:
Bachelor's Degree in Engineering or Science field.Mandatory 3+ years of QA experience in a medical device/Diagnostic company working on deviations, Nonconformances and CAPA processes.Working knowledge of NC and CAPA processes in accordance with medical device / in vitro diagnostic regulations (e.g., FDA 21 CFR 820, ISO 13485, IVDR, 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.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.
#LI-SH1
#LI-Remote
#LI-Hyrbid
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote roles- Tempus reasonably believes that criminal history may have a direct, adverse and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment: engaging positively with customers and other employees; accessing confidential information, including intellectual property, trade secrets, and protected health information; and appropriately handling such information in accordance with legal and ethical standards. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.