Quality Lead, Requirements and Specifications Management (Assay)

QuidelOrtho; Pompano Beach (FL); On-site; USD 135,000 - 175,000; Full time

Job summary

QuidelOrtho in the United States is seeking a Quality Lead, Requirements and Specifications Management (Assay) to drive end-to-end quality across a portfolio of assay-based medical devices. This global role partners with R&D, Systems Engineering, Regulatory, Manufacturing, and Product Management to ensure robust design inputs and compliant development.

The position requires a Bachelor's in Life Sciences or engineering, 7+ years in quality/compliance, and deep knowledge of ISO 13485, FDA 21 CFR

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related discipline.
• 7+ years in Quality, Compliance, or related fields in Medical Device/IVD/Biopharma.
• Knowledge of ISO 13485, FDA 21 CFR 820, IVDR.
• Proven success in leading Quality and Compliance initiatives aligned with strategy.
• Strong collaboration, influence, and cross-functional communication.
• Analytical skills and data-driven decision making.

Responsibilities

• 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.

Skills

Quality systems

Regulatory knowledge

Cross-functional collaboration

Data-driven decision making

Quality improvement

Education

Bachelor's degree in Life Sciences, Engineering, or related

Job description

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 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.

The Role

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 specifications-partnering 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 organization's 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 management.toend 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 specifications-partnering 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 organization's 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.

The Responsibilities

• 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.

The Individual

Required:

• Bachelor's 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.

Key Interactions

Internal: Operations, R&D, Commercial, Regulatory Affairs, Quality & Compliance teams globally and regionally

External: Regulatory agencies, Notified Bodies

Work Environment

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

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 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 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 $135,000 to $175,000 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.

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 [e-mail].