The Opportunity

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.

The Role

At QuidelOrtho, we’re advancing the power of diagnostics for a healthier future for all. Join our mission as our next Software Release Manager to join our R&D Instrument Platforms organization. This role combines scrum leadership with software release management accountability, focusing on the end-to-end planning, coordination, and execution of software releases for regulated medical device systems.

The Software Release Manager is embedded within Agile development teams while also maintaining a system-level view of SDLC, integration, and release readiness. This role ensures predictable, high-quality software releases by coordinating across multiple internal and external team members, managing dependencies, mitigating risk, and aligning execution with regulatory and business objectives.

This position will be working hybrid 2 days onsite at our San Diego (Summers Ridge) location.

The Responsibilities

Release Planning and Ownership

• Own end-to-end software release from planning through deployment, ensuring on-time, on-scope, and high-quality outcomes.
• Develop and manage integrated release plans, including dependencies, milestones, and critical paths along with resource forecasts.
• Coordinate cross-team integration activities to ensure system-level readiness and stability.
• Drive release readiness processes per metrics of definition of done, entry/exit criteria, and go/no-go decision support.
• Track Agile metrics (velocity, burndown, predictability) and team performance through disciplined management in systems like ADO.
• Remove impediments and foster a culture of accountability, collaboration, and continuous improvement.
• Plan, track and manage project costs within allocated budget.

Technical & System Awareness

• Maintain working knowledge of system architecture, software components, and integration points sufficient to anticipate release risks.
• Understand the technical state of work items to accurately assess progress and risks.

Risk, Quality, and Compliance

• Identify and proactively mitigate technical, schedule, quality, budget and integration risks.
• Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and internal design controls.
• Ensure audit readiness by ensuring documentation completeness and traceability across releases.
• Support internal and external audits.

Stakeholder & Vendor Management

• Serve as a primary Instrument Software interface at Project meetings.
• Coordinate across engineering, systems, quality, regulatory, and product stakeholders.
• Manage vendor relationships and external development partners, including statement of work, cost, milestones, performance, and change control.
• Provide clear, data-driven status reporting on release progress, risks, and mitigation plans.
• Communicate release scope, timelines, and readiness to leadership and cross-functional partners.

Continuous Improvement & Process Excellence

• Champion best practices in Agile Framework, DevOps, and release management.
• Identify opportunities to improve release predictability, quality, and team effectiveness.
• Coach teams and stakeholders in Agile best practices within a hybrid Scrum environment.
• Perform other work-related duties as assigned.

The Individual

Required:

• Bachelor’s degree, preferably in Computer Science, Software Engineering, or related STEM field (or equivalent experience).
• 8+ years of experience in software program management, Agile environments, or related experience.
• Demonstrated experience delivering complex software systems in cross-functional environments
• Experience managing schedules, budgets, resources, and vendor engagements
• Strong knowledge of Agile methodologies (Scrum) and release management practices.
• Experience with tools such as Azure DevOps, JIRA, or similar Agile lifecycle tools
• Ability to manage dependencies across multiple teams and systems
• Strong understanding of software development lifecycle and integration practices.
• Excellent communication skills with ability to translate technical concepts to business audiences.
• Strong ownership and accountability for software release outcomes.
• Ability to balance tactical team support with strategic oversight.
• Proven ability to identify and mitigate risks in complex systems.
• Effective cross-functional collaboration across engineering, QA, regulatory, and operations.
• Adaptability in fast-paced and evolving environments
• This position is not currently eligible for visa sponsorship
• Ability to travel up to 10%

Preferred:

• 3+ years of experience as Scrum Master or Agile team facilitator.
• Experience in regulated medical device software development.
• Familiarity with FDA, ISO 13485, and IEC 62304, and design control processes.
• Awareness of DevOps, CI/CD pipelines, and release automation.
• Experience working with distributed or external development teams.

The Key Working Relationships

Internal Partners:

• Software Engineering – daily execution, delivery, and integration
• Systems Engineering – system requirements and architecture alignment
• Verification & Validation – test planning and execution readiness
• Design Quality & Regulatory Affairs – compliance with regulatory standards
• Product Management / Marketing – release scope and prioritization
• Operations, Manufacturing, Service – downstream release readiness
• PMO, Finance – roadmap, funding, and release alignment

External Partners:

• Third-party software development partners
• Tooling, translation and cybersecurity vendors
• External auditors and regulatory bodies

How We Work

At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they’re essential to how we thrive as a team and achieve meaningful impact:

• Thrive Together – Collaborate intentionally, grow as a team
• Make It Happen – Focus on priorities, embrace continuous improvement
• Commit to Service – Cultivate a service mindset
• Embrace Inclusion – Be open and authentic, welcome diverse perspectives

The Work Environment

No strenuous physical activity, though occasional light lifting of files and related materials is required. 30% of time in meetings, working with team, or talking on the phone, 70% of the time at the desk on computer, doing analytical work. Minimal travel required. Travel includes airplane, automobile travel and overnight hotel.

Physical Demands

No strenuous physical activity required. Occasional light lifting of materials may be needed. Substantial time will be spent in virtual or in-person meetings, engaging with customers, and working on scientific content and documentation.

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 $140,000 to $160,000 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 [email protected].

#LI-TO1