Staff Quality Partner, Technical Quality Investigation

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 Staff Quality Partner, Technical Quality Investigation. The Staff Quality Engineer leads complex, long term, product focused quality investigations for invitro diagnostics, owning issues that affect form, fit, function, or on market performance from problem statement through verified, sustainable corrective and preventive actions. This role designs and executes rigorous investigative plans, applies advanced root-cause analysis and risk management, and leverages deep product and process knowledge to drive data driven decisions. The engineer interfaces with SQIR/PQR processes to support recall and field action recommendations, communicates investigation status, risks, and remediation plans to cross functional stakeholders and leadership, and partners closely with R&D, Manufacturing, Regulatory, and Post Market Surveillance. As an auditee, the role provides comprehensive global audit support and evidence of compliance. Success requires exceptional analytical and problem solving skills, critical thinking, and strong cross functional collaboration to ensure patient safety, product reliability, and compliance with applicable IVD quality system regulations and standards.

This role provides strategic direction and operational oversight across Quality disciplines-including Quality Systems, Compliance, Design Assurance, Quality Engineering, and Quality Control-ensuring alignment with global regulatory requirements (ISO 13485, FDA 21 CFR 820, IVDR, and other applicable standards). The Staff Quality Partner partners cross-functionally to embed Quality and Compliance principles throughout the product lifecycle, driving harmonization, inspection readiness, and continuous improvement.

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

This position will be onsite in Rochester, NY.

• Lead long term, product focused quality investigations for on market IVD products. term, product focused quality investigations for on market IVD products.term, productfocused quality investigations for onmarket IVD products.

• Own and execute investigations impacting product form, fit, function, and performance.

• Design, plan, and conduct rigorous investigative studies using structured root cause methodologies. cause methodologies.cause methodologies.

• Apply risk management principles to assess patient, product, and business impact and guide decision making. management principles to assess patient, product, and business impact and guide decision making.management principles to assess patient, product, and business impact and guide decisionmaking.

• Interface with SQIR/PQR processes to inform recall and field action recommendations.

• Develop, present, and communicate investigation updates, findings, and corrective actions to cross functional stakeholders and leadership. functional stakeholders and leadership.functional stakeholders and leadership.

• Collaborate with R&D, Manufacturing, Regulatory, Post Market Surveillance, and other partners to drive effective problem resolution.Market Surveillance, and other partners to drive effective problem resolution.

• Ensure investigations and documentation comply with applicable IVD quality and regulatory requirements.

• Provide global audit support as an auditee, including investigation summaries, evidence, and corrective action records.

• Promote strong analytical thinking, critical reasoning, and high quality problem-solving throughout the organization.quality problem-solving throughout the organization.

• Establish clear priorities, assign responsibilities, and ensure effective resource allocation to meet business and compliance needs.

• Provide technical, regulatory, and operational leadership to ensure Quality systems comply with ISO 13485, FDA 21 CFR 820, IVDR, and other applicable requirements.

• Promote a culture of continuous improvement.

• Ensure the team maintains a state of inspection readiness and supports successful engagement with regulatory agencies, notified bodies, and internal audits.

• Monitor Quality performance using metrics and data analytics to identify risks, drive root cause analysis, and implement sustainable improvements.

• Coach and mentor emerging Quality team members to 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.

Required:

• Bachelor's 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.

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 recruiting@quidelortho.com.

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