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Senior Quality Engineer

Remote:

Full Remote

Contract:

Full time

Experience:

Senior (5-10 years)

Work from:

Illinois (USA), United States

Offer summary

Qualifications:

BA/B.S. in relevant field preferred, 5+ years in FDA regulated domain, 3+ years in Computer System Validation, Knowledge of medical device and CSV standards, Ability to work under minimal supervision.

Key responsabilities:

Lead verification, validation and maintenance activities
Support regulatory compliance for Tempus Medical Devices
Develop and maintain CSV policies and procedures
Perform software validation and change controls
Provide guidance and mentorship to test engineers

Tempus Biotech: Biology + Technology Unicorn https://www.tempus.com/

1001 - 5000 Employees

See more Tempus offers

Job description

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.

As a Senior Software Quality Engineer, you will:

Lead verification, validation and maintenance of host and computer systems supporting Tempus Medical Device(s).
Lead risk assessments to determine testing strategies.
Be involved in the medical device software design controls activities, in accordance with the FDA Quality System Regulation, ISO 13485, GAMP5, Computer System Validation (CSV) standards and FDA guidance, other applicable regulatory requirements, as well as best practices in the software industry.
Lead computer system validation (CSV) activities of AI applications, software tools, and computer systems against user, functional and regulatory requirements.

Responsibilities:

Support regulatory compliance of the host system operating with Tempus Medical Device(s) (e.g. xT CDx).
Develop and maintain CSV policies, procedures, templates and work instructions.
Lead risk-based approach to host / computer system validation (HSV/CSV), SDLC and design controls activities.
Perform validation, re-validation and change controls of various AI, SaaS/OTS, and Tempus in-house developed software.
Author and review software validation deliverables, including Risk Assessments, Validation Plans, Requirements (URS), Validation Protocols (IQ, OQ, PQ), UAT (User Acceptance Test), and Validation Reports.
Collaborate with cross-functional teams in developing test-driven system/functional requirements, defining testing strategies and participating in test execution.
Support Change Management and Major Incidents (MI) processes, ensuring organizational compliance and continuous improvement.
Provide support to Quality and IT organizations in maintaining compliance to various policies, procedures and activities, including support during internal/external inspections and regulatory and customer audits.
Provide CSV guidance, coaching, mentorship, and training to test engineers within the team.

Qualifications

BA/B.S. or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines.
5+ years experience in FDA regulated domain (e.g. medical device, pharma, biotech)
3+ years experience in Computer System Validation (CSV).
Experience with industry standards and best practices for Medical device software and CSV such as Design Controls, GAMP 5, FDA 21 CFR Part 11, FDA (QSR) FDA 21 CFR 820.30, Medical device software (QMS) ISO 13485:2016, FDA 21 CFR 820, and Software life cycle processes (IEC 62304:2006).
Knowledge of quality system principles, practices, and standards for the life science industry.
Ability to deliver quality outputs without directions or under minimal supervision.
This position may be remote.

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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.