Principal GSO Quality Parnter

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 GSO Quality Partner Product Health and Monitoring. ThePrincipal GSO QualityPartnerisa globalindividual contributorwithinQuidelOrtho sGlobal Quality & Compliance (GQ&C) organization. Thisindividualis responsible to ensure the design implementation and continuous improvement of Quality systems processes and programs that enableQuidelOrtho sRight to Operate and support business agility innovation and role provides strategic direction and operational oversight across Quality disciplinesincluding Quality Systems Compliance Design Assurance Quality Engineering and Quality Controlensuring alignment with global regulatory requirements (ISO 13485 FDA 21 CFR 820 IVDR and other applicable standards). ThePrincipal GSO Quality Partner partners cross-functionally to embed Quality and Compliance principles throughout the product lifecycle driving harmonizationinspectionreadiness and continuous improvement. Thisindividualis responsible forfostering a culture of engagement collaboration and performancewith the Global Service Organization. By integrating technicalexpertiseanddata-driven insightsthePrincipal GSO Quality Partnerensures that Quality systems deliver sustainable business and compliance outcomes.

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

The Responsibilities

• Establishclear priorities assign responsibilities and ensure effective resource allocation to meet business and compliance needs.

• Provide technical regulatory and operational leadership to ensure Quality systemscomply withISO 13485 FDA 21 CFR 820 IVDR and other applicable requirements.

• Drive harmonization and standardization of Quality processes procedures and tools across sites and functions to strengthen compliance and efficiency.

• Primarily partners with the Global Service Organization in addition toOperations R&D Regulatory Affairs and other stakeholders to integrate Quality and Compliance principles throughout the product lifecycle.

• Promote a culture of continuous improvement byidentifyingopportunities for simplification process excellence and digital enablement within the Quality Management System (QMS).

• Ensure the teammaintainsa state of inspection readiness and supports successful engagement with regulatory agencies notified bodies and internal audits.

• MonitorQuality performance using metrics and data analytics toidentifyrisks drive root cause analysis and implement sustainable improvements.

• Coach and mentor emerging Qualityteam membersto build organizational capability and ensure robust succession planning.

• Communicate Quality and Compliance strategy progress and risk mitigation plans to senior leadership and cross-functional stakeholders.

• Perform other work-related duties as assigned.

The Individual

Required:

• Bachelors degree in Life Sciences Engineering ora relatedtechnical disciplinerequired.

• 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.

• Demonstratedsuccess 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.

• Experience with customer complaint handling processessuch asproduct trending andcustomer communication activities.

• Experience with working across a matrix-based organization to drive collaboration and achieve results.

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

• Temperature: Extreme heat or cold

• Noise level: Sounds or a pitch that may cause distraction

• Location: Inside or outside such as an office or outdoors

• Weather: Wet and/or humid conditions outside weather conditions

• Exposures: Hazardous materials fumes toxic chemicals airborne particles odors or other unpleasant surroundings

• Workspace: Traditional workspace or remotely

• Other factors: Frequent overtime extensive travel emergency staff designations or being on-call

The Physical Demands

• Sitting standing walking lifting carrying reaching pushing and pulling.

• Other physical demands include bending crawling stooping vision grasping climbing or balancing kneeling crouching talking or hearing tasting or smelling.

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 $155000 to $202000 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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