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
As we continue to grow as QuidelOrtho, we are seeking a Software V&V Engineer II to support out Transfusion Medicine team. This person will execute verification tests for Transfusion Medicine and will work in a FDA regulated environment.
This position will be onsite in Rochester, NY.
The Position
Develop and execute verification and validation activities.Define test strategy, design and develop test cases from software requirements and architecture designs, for complex embedded real-time systemsExecute test procedures, record and later follow-up anomalies found during testing.Communicate Test development and Execution status to Team LeaderEffective written and oral communication.Excellent problem-solving and trouble-shooting skills, and ability to work independently are required.Excellent organizational skills and attention to details are required.Good interpersonal skills are required.Experience in defining and collecting software quality metrics is preferred.Perform other work-related duties as assigned.The Individual
Required:
A minimum of a Bachelor’s degree in a Scientific, Software or Medical Technology disciplineExperience in a regulated industry: FDA 21 CFR 820, the Quality System Regulation, ISO 13485, and IEC 62304 is preferred.Professional verification and validation experience in a Unix or Windows environmentsTechnical ability to understand the mechanical, electrical and software components of the system is required.3+ years Experience in a lab environment in the Transfusion Medicine industryExperience with Vision, Optix and OrthoConnect instrumentsExperience with Automated Verification TestingExperience writing technical documentation using MS OfficeExperience configuring and using software automated testing tools like HP Quick Test Professional is a plusKnowledge of development environment tools like Serena Business Mashups, HP Quality Center, IBM/Rational DOORS, Aligned Elements, and Microsoft Team Foundation Server.Experience with Jira, Windchill and Quality Center a plusThis position is not currently eligible for visa sponsorship.The Key Stakeholders
Internal Partners:
All levels of the organization.External Partners:
Vendors and customers.The Work Environment
The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines
Physical Demands
This person must have the ability to work in a BL2 lab environment. Use of PPE as required. Up to 50% working in the lab, standing or sitting extended periods of time. may require testing in a Bio-hazardous lab environment, training will be provided. Bio-hazardous fluids may be used in testing.
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 $75,000 to $95,000 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.