Validation engineer

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

As we thrive together QuidelOrtho is seeking a Verification and Validation Engineer II to help with formal verification and validation of complex medical devices under the regulations of the FDA. The individual will be part of an engineering team that is responsible for requirements-based test design and execution of test procedures in a BL2 lab environment. The team is highly collaborative and will require regular interactions in formal reviews, test planning activities, and working with software development to

reproduce and verify system defects.

This position is onsite full-time in Rochester, NY.

The Responsibilities

• Develop Requirements based manual test procedures using HP ALM Quality Center
• Execute test procedures both in a virtual and lab environment
• Compile and analyze test results
• Access requirements for testability and determine best test approach
• Document and manage system software defects
• Participate in regular scheduling and team meetings
• Document and manage Test plans, Tracing and Reports
• Perform other work-related duties as assigned.
  
  

The Individual

Required

• This position is not currently eligible for visa sponsorship.
• B.S. Degree in Computer Science, Chemistry, Biochemistry, Biology, Engineering, or a related discipline
• 3-5 years’ experience working within a FDA regulated environment supporting software development or quality control
• Critical thinking, effective communication and strong documentation practices
• Ability to travel up to 10% (domestically)
  
  

Preferred

• Agile methodology, Jira, HP ALM Quality Center, Virtual Box, VMware and Unix experience
  
  

The Key Working Relationships

Internal Partners

• Cross functionally with Software Development, Integration, Project Management and Design Quality
  
  

External Partners

• Software Development partners
  
  

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. Duties will change between lab environment and office. Flexible work hours to meet project deadlines

Physical Demands

No strenuous physical activity, though occasional light lifting of files and related materials is required.

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 $80,000 to $90,000 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].