Design Transfer & Tech Transfer Strategy

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 Principal Quality Partner Design and Tech Transfer Strategy (Assay). The Design and Tech Transfer Strategy Principal Quality Partner is a global individual contributor within QuidelOrtho s Global Quality & Compliance (GQ&C) organization. This individual is responsible to ensure the design implementation and continuous improvement of Quality systems processes and programs that enable QuidelOrtho s Right to Operate and support business agility innovation and growth.

The Principal Quality Engineer for Design & Technology Transfer Strategy (Assay) serves as a senior technical leader within the Quality organization responsible for driving robust compliant and efficient design transfer and technology transfer strategies for invitro diagnostic (IVD) assays. This role partners closely with cross functional teamsincluding R&D Tech Transfer Design Quality and Operationsto ensure that new products and process changes are transferred seamlessly into manufacturing with full adherence to global regulatory expectations. The Principal Quality Partner provides authoritative interpretation of quality and regulatory requirements deep product and process expertise and proactive quality oversight to enable successful commercialization lifecycle changes and global inspection diagnostic (IVD) assays. This role partners closely with crossfunctional teamsincluding R&D Tech Transfer Design Quality and Operationsto ensure that new products and process changes are transferred seamlessly into manufacturing with full adherence to global regulatory expectations.

This individual is responsible for fostering a culture of engagement collaboration and performance. By integrating technical expertise and data-driven insights the Principal Quality Partner ensures that Quality systems deliver sustainable business and compliance outcomes.

This position will be onsite in Rochester NY.

The Responsibilities

• Serve as the primary Quality partner to the Technology Transfer team providing strategic guidance and oversight throughout assay design transfer and tech transfer activities.

• Lead development and execution of comprehensive design transfer and technology transfer quality strategies that ensure compliant sustainable product realization.

• Collaborate with Design Quality Quality Operations R&D and Manufacturing teams to ensure alignment on design transfer deliverables risk management and process capability expectations.

• Provide expert interpretation of applicable global regulatory and quality system requirements (e.g. ISO 13485 IVDR FDA QSR) as they relate to design transfer process transfer verification/validation and manufacturing readiness.

• Apply deep product and process knowledge to assess transfer risks guide process understanding and ensure adequate controls are defined and implemented during scaleup.

• Support global audit and inspection activities as a subject matter expert and auditee for design transfer tech transfer and related quality system elements.

• Proactively identify quality gaps systemic risks and continuous improvement opportunities within design transfer frameworks and lead cross-functional teams to implement opportunities within design transfer frameworks and lead cross-functional teams to implement solutions.

• Mentor engineers and contribute to development of organizational capability in design transfer strategy and regulatory compliance.

• Perform other work-related duties as assigned.

The Individual

Required:

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

• 10 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.

• Strong product and process knowledge relevant to assay development verification/validation and manufacturing workflows.

• 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.

• Expert-level knowledge of Design Transfer and Technology Transfer for IVD assays including process readiness scaleup and transfer of product requirements into manufacturing.

• Deep understanding of IVD regulatory and quality system requirements such as ISO 13485 IVDR FDA QSR risk management (ISO 14971) and design control principles.

• Strong product and process knowledge relevant to assay development verification/validation and manufacturing workflows.

• Ability to interpret complex regulatory requirements and translate them into actionable design transfer and quality strategies.

• Demonstrated experience evaluating process capability process controls and design outputs to ensure manufacturability and compliance.

Preferred:

• Strong analytical and systemsthinking skills to evaluate endtoend product realization pathways.

• Ability to anticipate risks in design transfer and proactively implement mitigation strategies.

• 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: Tech Transfer Operations Supply Chain R&D Commercial Regulatory Affairs and other 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 $135000 to $175000 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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