The Davis Companies · 2 hours ago
Senior Software Quality Engineer
United States
Contract
Remote
Senior LevelThe Davis Companies is seeking a Senior Software Quality Engineer with experience in the medical space. This role is essential for taking ownership of software quality, compliance, and documentation efforts while collaborating closely with R&D to enhance the software quality ecosystem.
Property ManagementReal Estate
Hiring Manager
Carl W.
Responsibilities
Lead all software quality and lifecycle compliance activities for ongoing and future projects
Drive V&V efforts, including verification and validation planning, execution, and documentation
Validate tools and spreadsheets (formulas, protocols) to ensure FDA compliant outputs
Perform code-level reviews, debugging analysis, and unit test oversight (no coding required, but technical fluency is essential)
Collaborate with R&D to build intuitive, compliant SDLC templates and processes
Apply deep knowledge of software risk management and safety requirements (14971, 62304, Part 820)
Work autonomously as a senior-level or architect-level contributor who can take ownership of the project
Qualification
Required
Experience in the medical space
Ownership of software quality, compliance, and documentation efforts
Proactively lead, audit, and strengthen procedures aligned with FDA, MDR, CFR Title 21 Part 820, ISO 14971, and IEC 62304
Lead all software quality and lifecycle compliance activities for ongoing and future projects
Drive V&V efforts, including verification and validation planning, execution, and documentation
Validate tools and spreadsheets (formulas, protocols) to ensure FDA compliant outputs
Perform code-level reviews, debugging analysis, and unit test oversight (no coding required, but technical fluency is essential)
Collaborate with R&D to build intuitive, compliant SDLC templates and processes
Apply deep knowledge of software risk management and safety requirements (14971, 62304, Part 820)
Work autonomously as a senior-level or architect-level contributor who can take ownership of the project
Strong background in software quality engineering, including specifically IEC 62304 documentation
Proven ability to build, update, and maintain FDA & MDR-compliant SW quality documentation
Experience partnering with cross-functional engineering teams to ensure robust design controls that withstand FDA/MDR audits
Ability to perform architecture and code design reviews with a quality and safety mindset
Experience with software quality for medical devices; familiar with CFR Title 21 Part 820
Cybersecurity experience required
Must be able to operate beyond documentation & contribute meaningfully to technical discussions and reviews
Ability to thrive in a scale-up environment, wearing multiple hats and driving work with minimal oversight
Company
The Davis Companies
The DAVIS Companies is a preferred source for Staffing Solutions and Talent Advisory Services, specializing in contract, contract-to-hire and direct hire staffing for Engineering, Skilled Manufacturing, IT and Software personnel.
Founded in 1985
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Mark Agostinelli
President
Recent News
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2024-12-17
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