Staff Design Quality Engineer

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 Staff Quality Engineer, Design Quality (QE) supporting our instrument or assay lifecycle development. The Staff QE works

independently under the direction of a manager and is responsible to ensure that QuidelOrtho products are developed in compliance with QuidelOrtho product delivery procedures, the QuidelOrtho Quality Management System, and worldwide design control regulations, and that subsequent lifecycle design change controls are effective.

This position will be onsite working a hybrid schedule (2-3 days onsite) - open to San Diego, CA or Rochester, NY offices.

The Position

• As an authority in QuidelOrtho's design and development process, the QE provides direction to design and development teams and is responsible for ensuring compliant completion of key design control deliverables, and documentation to support efficient worldwide regulatory submissions.
• Responsible for comprehensive design history and management of risk management files.
• Interface with global manufacturing facilities and external partners for effective technology transfer of new products and maintenance of lifecycle design quality.
• Performs other work-related duties as assigned

The Individual

Required:

• Bachelor of Arts / Bachelor of Science in Life Sciences, Engineering, or Physical Science required OR 8+ years equivalent experience in technical and/or quality systems with BA/BS in a related field. Master of Arts /Master of Science in Life Sciences, Engineering, or Physical Science preferred.
• A minimum of 7 years of experience with BS in Life Sciences, Engineering, or Physical Sciences, or 5 years of experience with MS in these fields with a strong preference for experience in a functional Quality role.
• Experience working with medical devices.
• Experience in handling external and internal regulatory inspections.
• Understanding/training in FDA CFR Part 820, Part 11, and ISO 13485 regulations.
• Advanced oral and written communication skills, including the ability to write technical reports and presentations.
• Computer skills/data analysis skills (Example: Word, Excel, PowerPoint, Minitab, Visio, and MS Project).
• Ability to travel up to 10%
• This position is not currently eligible for visa sponsorship.

Preferred:

• Experience as a quality engineer, including risk management/risk-based analysis,
• nonconformance, root cause investigation and corrective/preventive action is preferred.
• Experience in FMEA or FTA is preferred.
• Strong project management skills.
• Process Excellence Black Belt or Green Belt with strong problem-solving skills.
• Experience working with instrument software or assay development.

The Key Stakeholders

Internal Partners:

• R&D/Product Support - New product and lifecycle management (LCM) - Primary business partner for new product and LCM projects.
• Project/Program Management - Business partner for new product and LCM projects.
• Regulatory Affairs - Partner to integrate current regulatory expectations into Design Control/ Design Change control processes - facilitate content development for submissions.
• Operations/Engineering/Operations Quality - Partner for effective design transfer to internal and external partner locations for new development and design change.
• Post Market Risk Management - Shared accountability for Product Risk management lifecycle; Integrating Post-market surveillance lessons learned/CAPA into product development processes. Management - Provide updates regarding projects.

External Partners:

• Suppliers/ External Manufacturers: Directly or indirectly support design transfer and design change control activities.
• External Development Service Providers: Define accountabilities between companies for Design Control elements on a project by project basis, monitor quality activities and project deliverables for adherence to regulatory requirements.

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.

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 $120,000 to 145,000 depending on location (San Diego, CA or Rochester, NY 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.