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Senior Software Quality Engineer - Medical Devices

Remote:

Full Remote

Contract:

Full time

Experience:

Senior (5-10 years)

Work from:

Illinois (USA), United States

Offer summary

Qualifications:

BA/B.S. or higher in relevant field, 5+ years in medical device quality role, Knowledge of FDA QSR and ISO standards, Expertise in SDLC best practices, Experience with Agile/Scrum methodology.

Key responsabilities:

Lead software quality for SDLC projects
Provide FDA/ISO mentoring to teams
Generate and maintain quality documentation
Apply risk-based compliance approaches
Support QMS procedures and audits

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

1001 - 5000 Employees

See more Tempus offers

Job description

Your missions

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.

We are looking for a Senior Software Quality Engineer (Software Design Controls) who will be involved in the software quality management system (QMS) and software development life cycle (SDLC) activities, in accordance with FDA’s Quality System Regulation (QSR), ISO 13485, CAP/CLIA, and other applicable regulatory requirements, as well as best practices in the software industry. You will report to the Manager of Software Quality and will play a key role in producing quality software products.

Responsibilities:

Serve as Software Quality lead for Tempus’ SDLC projects/activities that include laboratory developed tests, investigational device software, and commercialization of medical devices (SiMD and SaMD).
Provide FDA/ISO Design Controls mentoring to various cross-functional teams, including R&D, lab operations, software engineering, bioinformatics, and IT teams.
Ensure applicable quality required documentation, such as DHF deliverables, are generated and maintained throughout SDLC of software products, including SRS, SAD, SDS, V&V, traceability, risk management/FMEA and cyber-security.
Apply innovative, scalable, and risk-based approaches to meeting compliance for novel technologies in a fast-paced, multi-project environment.
Maintain knowledge of the evolving regulatory landscape for Digital Health, Artificial Intelligence and Machine Learning technologies, and incorporate best practices in Tempus’ SDLC processes and QMS.
Support compliance to various QMS procedures and activities including, but not limited to risk management, internal and external audits, change control, and training.
Support and own software QMS procedures.
Performs other related duties and responsibilities as assigned.

Required Education & Experience:

BA/B.S. or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines.
5+ years in a software quality (design assurance/controls) role in the medical device/IVD (or FDA regulated) industry.
Experience and working knowledge of applicable regulations and standards: FDA QSR, ISO 13485, IEC 62304, ISO 14971
Expertise in SDLC best practices, and experience with state-of-the-art SDLC tools such as Atlassian (Jira) and Jama.
Experience with Agile/Scrum/iterative software development methodology.
Ability to deliver quality outputs under minimal supervision.

#LI-SH1

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.