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.

As we continue to grow as one QuidelOrtho we are seeking a Senior Design Quality Engineer. The Senior Design Quality Engineer is a senior individual contributor within QuidelOrtho' s Global Quality & Compliance (GQ&C) organization. This role provides technical support in the execution, oversight, and continuous improvement of Quality systems, processes, and programs that enable compliant product development and support business agility, innovation, and growth. The Senior Engineer provides subject‑matter expertise across the product design lifecycle, with substantial responsibility for Design Controls and Risk Management for IVD product development. This role ensures that user needs, requirements, and claims are scientifically justified and translated into robust, testable criteria that support safe and effective product performance. As a key Quality partner for cross‑functional development teams, this role leads Quality engineering activities related to design changes, validation strategies, and claim verification approaches. The Senior Engineer also represents Quality during regulatory inspections, notified body audits, and internal audits as a technical authority. This role ensures alignment with global regulatory requirements (ISO 13485, FDA 21 CFR 820, IVDR, and related standards) and demonstrates strong technical depth, systems thinking, and the ability to navigate complex, fast‑paced environments while promoting a proactive and collaborative Quality culture. The Senior Design Quality Engineer partners cross‑functionally to embed Quality and Compliance principles throughout the product lifecycle and contributes to harmonization, inspection readiness, and continuous improvement initiatives. The role also supports organizational capability by mentoring others, driving technical problem‑solving, and contributing to a culture of engagement, scientific excellence, and high performance. By integrating technical expertise, data‑driven insights, and strong Quality discipline, the Senior Engineer ensures that Quality systems and processes deliver sustainable business and compliance outcomes.

This position will be onsite in Rochester, NY or San Diego CA.

• Support complex Quality engineering activities that support business and compliance priorities, ensuring timely delivery and high technical rigor.
• Apply technical, regulatory, and Quality systems knowledge to ensure compliance with ISO 13485, FDA 21 CFR 820, IVDR, and other applicable standards.
• Support the harmonization and standardization of Quality processes, procedures, and tools across sites and functions to strengthen consistency and efficiency.
• Collaborate closely with R&D, Regulatory Affairs, Manufacturing, Supply Chain, and other stakeholders to integrate Quality and Compliance principles throughout the product lifecycle.
• Drive continuous improvement initiatives, identifying opportunities for simplification, process optimization, and digital enablement within the Quality Management System (QMS).
• Support a high level of inspection readiness and serve as a Quality representative during regulatory agency inspections, notified body audits, and internal audits.
• Provide coaching and technical guidance to peers, junior engineers, and project teams to strengthen organizational Quality and scientific capability.
• Communicate Quality‑related risks, recommendations, and progress to project teams, cross‑functional partners, and Quality leadership.

• Perform other work-related duties as assigned.

Required:

• Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline required.

• 5+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries.
• Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR.
• Demonstrated success driving Quality and Compliance initiatives that align with business strategy and regulatory expectations.
• Excellent collaboration, influence, and communication skills across functional and organizational boundaries.
• Strong analytical and problem-solving skills, with experience using data to drive decision-making and improvement.
• Commitment to scientific integrity, compliance excellence, and continuous improvement.

Preferred:

• Advanced degree (MS, PhD, MBA, or equivalent) in a relevant discipline.

• Experience implementing or optimizing global Quality Management Systems (QMS) and digital tools.

• Lean Six Sigma, PMP, or similar certification demonstrating process improvement expertise.

• Experience supporting or leading Health Authority or Notified Body inspections.

Internal: Operations, Supply Chain, R&D, Commercial, Regulatory Affairs, GSO, Quality & Compliance teams globally and regionally.

External: Regulatory agencies, Notified Bodies, Contract manufacturers, Suppliers, and service providers.

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment.

No strenuous physical activity required. May include occasional travel for site visits, leadership meetings, or regulatory support.

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

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 that facts and circumstances of each case. Salary range for this position is $102,000 to $133,000 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.

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 their 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-SP1