Design Quality 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 6000 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 one QuidelOrtho we are seeking a Staff Design Quality Engineer. The Staff Design Quality Engineer is a key contributor within QuidelOrtho s Global Quality & Compliance (GQ&C) organization. This role is responsible for executing and supporting Quality systems processes and programs that ensure compliant product development and enable business agility innovation and growth. The Staff Engineer provides technical expertise across the product design lifecycle with focus areas that include Design Controls and Risk Management for IVD products. The role ensures that user needs requirements and claims are clearly defined scientifically justified and translated into testable acceptance criteria. As a primary Quality partner for crossfunctional development teams this role supports the evaluation of design changes contributes to validation and claim verification strategies and represents Quality during audits and inspections. This role is responsible for ensuring work is aligned with global regulatory requirements (ISO 13485 FDA 21 CFR 820 IVDR and other applicable standards). Success in this position requires strong technical depth attention to detail and the ability to operate effectively in a complex fastpaced environment while supporting a proactive quality culture. The Staff Design Quality Engineer partners across functions to embed Quality and Compliance principles throughout the product lifecycle supporting harmonization inspection readiness and continuous improvement. This role also contributes to building technical capability within the organization by sharing expertise supporting problemsolving and promoting collaborative highperformance team behaviors. By integrating scientific rigor datadriven decisionmaking and strong Quality fundamentals the Staff Engineer helps ensure that Quality systems and processes deliver sustainable business and compliance outcomes.

This position will be onsite in Rochester NY.

The Responsibilities

• Execute Quality engineering activities that support business and compliance needs ensuring timely delivery of highquality outputs.

• Apply technical regulatory and Quality systems knowledge to ensure compliance with ISO 13485 FDA 21 CFR 820 IVDR and other applicable requirements.

• Support harmonization and standardization of Quality processes procedures and tools across sites and functions to improve consistency and efficiency.

• Partner with R&D Regulatory Affairs Manufacturing Supply Chain and other stakeholders to integrate Quality and Compliance principles throughout the product lifecycle.

• Identify and support continuous improvement opportunities including simplification process excellence and digital enablement within the Quality Management System (QMS).

• Maintain a state of inspection readiness and participate in regulatory agency notified body and internal audit activities as a Quality representative.

• Utilize Quality metrics and data analytics to identify risks support root cause analysis and implement sustainable corrective and preventive actions.

• Mentor and provide technical guidance to peers and junior team members to strengthen organizational capability.

• Communicate Qualityrelated risks progress and recommendations to project teams and crossfunctional stakeholders.

• Perform other work-related duties as assigned.

The Individual

Required:

• Bachelors degree in Life Sciences Engineering or a related technical discipline required.

• 7 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.

Key Interactions

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.

Work Environment

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

The Physical Demands

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

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 theyre 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 Transparency

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 $102000 to $133000 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 Employment 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 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 .

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