Quality Lead, Requirements and Specifications Management (Assay)

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.

As we continue to grow as one QuidelOrtho we are seeking a Quality Lead Requirements and Specifications Management (Assay). The Quality Lead Requirements and Specifications Management (Assay) 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. This role provides strategic direction and operational oversight across product lifecycle quality with responsibility for defining owning and continuously improving the end to end requirements and specifications framework for a portfolio of assay based medical device products. This role establishes standardized processes templates and best practices that ensure product system and manufacturing requirements are clear traceable compliant and fit for purpose across the entire product lifecycle. The Quality Lead works cross-functionally to embed Quality and Compliance principles throughout the product lifecycle.

This individual acts as the subject matter authority for requirements and specificationspartnering closely with R&D Systems Engineering Design Quality Regulatory Affairs Manufacturing and Product Management to ensure robust design inputs that enable compliant scalable and high quality product development. This role is responsible for the governance definition and continuous improvement of the organizations assay requirements and specifications of management processes. This role functions as the enterprise subject matter expert and process owner leading through influence expertise and accountability rather than people requirements and specifications framework for a portfolio of assaybased medical device products. This role establishes standardized processes templates and best practices that ensure product system and manufacturing requirements are clear traceable compliant and fit for purpose across the entire product lifecycle.

The Quality Lead works cross-functionally to embed Quality and Compliance principles throughout the product lifecycle driving This individual acts as the subjectmatter authority for requirements and specificationspartnering closely with R&D Systems Engineering Design Quality Regulatory Affairs Manufacturing and Product Management to ensure robust design inputs that enable compliant scalable and quality product development. This role is responsible for the governance definition and continuous improvement of the organizations assay requirementsmatter expert and process owner leading through influence expertise and accountability rather than people management. This individual is responsible for fostering a culture of engagement collaboration and performance. By integrating technical expertise and data-driven insights the Quality Lead ensures that Quality systems deliver sustainable business and compliance outcomes.

This position will be onsite at any major site.

• 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.

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

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

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

• 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:

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

• 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 R&D Commercial Regulatory Affairs Quality & Compliance teams globally and regionally

External: Regulatory agencies Notified Bodies

Typical office or laboratory environment. May involve virtual collaboration across multiple global sites.

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 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 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.

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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