Senior Computer System Validation Csv Jobs in Rochester, NY

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

At QuidelOrtho, we're advancing the power of diagnostics for a healthier future for all. Join our mission as our next Senior DevOps Engineer to join our R&D Instrument Platforms organization. This role will focus on the design, implementation, and operation of Azure DevOps-centric CI/CD pipelines that support safetycritical, regulated medical device software. The DevOps Engineer will partner closely with Software, Systems, and Quality teams to enable reliable, repeatable, and auditable build and release workflows across a distributed Linux-based product portfolio.

This is an opportunity to shape build, release, and compliance infrastructure, including software bill of materials (SBOM) generation and Yocto-based embedded Linux build pipelines, within a regulated quality management system.

This position is remote eligible but candidates local to Rochester, NY are highly desirable.

NOTE: If you are working remotely, you must be able to travel to Rochester, NY on as-needed basis (about once a quarter).

The Responsibilities

This role is responsible for enabling secure, scalable, and traceable software delivery pipelines with Azure DevOps Pipelines as the primary CI/CD platform, while supporting long-lived medical device programs.

• Design, implement, and maintain CI/CD pipelines using Azure DevOps Pipelines as the system of record.
• Integrate Azure DevOps and/or GitHub repositories with Azure DevOps pipelines where applicable (e.g., GitHub-hosted code with Azure-hosted CI/CD and artifacts).
• Define and enforce branching strategies, pull request policies, build validation, and release gates within Azure DevOps.
• Create and maintain automated build pipelines for Yocto-based embedded Linux applications, including cross-compilation and image generation.
• Implement Software Bill of Materials (SBOM) generation and publication as part of the CI/CD pipeline to support cybersecurity and regulatory requirements.
• Integrate build pipelines with static analysis, test execution, code coverage, and quality reporting tools.
• Integrate requirements/PLM systems with verification tooling (test management, automated execution, and reporting) to enable end-to-end traceability from requirements to test evidence and release artifacts.
• Establish artifact management and versioning strategies using Azure DevOps Artifacts or equivalent repositories.
• Support containerized build environments (Docker and/or Podman) to ensure reproducible and deterministic builds.
• Partner with Quality and Regulatory stakeholders to ensure pipelines support traceability, auditability, and controlled releases in a regulated development lifecycle.
• Monitor, troubleshoot, and optimize pipeline reliability, performance, and cost.
• Act as a DevOps subject matter expert, providing guidance, documentation, and onboarding support for development teams.
• Help configure and manage Azure DevOps project.
• Support secure credential handling, secrets management, and leastprivilege access within pipelines.
• Perform other work-related duties as assigned.

The Individual

Required:

• B.S. or M.S. Degree in Computer Science, Computer Engineering, Software Engineering or a related discipline required.
• Minimum of 5 years of experience in DevOps, build engineering, or platform engineering roles.
• Strong, hands-on experience with Azure DevOps Pipelines as a primary CI/CD platform.
• Solid experience integrating GitHub with Azure DevOps for source control, PR workflows, and build validation.
• Proficiency with Git, including branching strategies and release flows.
• Experience generating and managing Software Bill of Materials (SBOMs) as part of automated build workflows.
• Strong Linux expertise, including scripting and troubleshooting in build environments.
• Familiarity with containerized builds using Docker and/or Podman.
• Experience integrating automated build, test, and quality checks into CI/CD pipelines.
• Strong analytical and debugging skills with a systematic approach to diagnosing pipeline and infrastructure failures.
• Ability to travel 15% or less, domestically, if working remotely.

Preferred:

• Experience working in regulated software development environments (e.g., FDA, ISO 13485, IEC 62304, or similar).
• Experience designing and maintaining Yocto build pipelines for embedded Linux environments.
• Experience managing self-hosted Azure DevOps build agents, including Linux-based and containerized agents.
• Scripting experience using Python, Bash, or PowerShell for automation and tooling.
• Familiarity with secure DevOps practices, including secrets management and pipeline hardening.
• Experience integrating PLM/ALM/requirements systems with test management and automation tooling to support traceability (requirements test cases results) and generation of audit-ready verification evidence.
• Demonstrated experience standing up an end-to-end software delivery pipeline from greenfield (source control and branching strategy, CI/CD, artifact management, quality gates, automated testing, traceability/evidence workflows, and operational governance).
• Experience supporting multi-repository or monorepo architectures with shared CI/CD patterns.
• Familiarity with C++, CMake, and similar programming tools used in build and release workflows.
• Familiarity with SonarQube or similar static analysis tools, including integrating analysis into CI/CD pipelines.
• Experience integrating AI-assisted tooling into development and release workflows (e.g., AI code review, automated PR feedback, or release risk assessment).
• Familiarity with dashboard design and reporting within Azure DevOps (e.g., Analytics, dashboards) or similar environments such as Grafana.
• Exposure to embedded systems, crosscompilation toolchains, and longlifecycle products.

The Key Working Relationships

Internal Partners:

• Software Engineers, Systems Engineers, Quality/Regulatory, Operations, IT / Infrastructure, Manufacturing, Service, Clinical Medical Affairs, Project Management Office

External Partners:

• Software development partners and suppliers.

The Work Environment

This role is based at our beautiful waterfront campus with walking trail, fitness center, and full-service onsite cafeteria in the Rochester, NY region.

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment. Up to 60% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines

Physical Demands

Must be able to work at desk, standing or sitting for extended periods of time. Other physical demands include bending, kneeling, talking, hearing, and vision.

Salary Transparency

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $100,000 to $120,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

Equal Opportunity

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com.

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