Quality Lead, Requirements and Specifications Management (Assay)

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.‑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, driving 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 ‑quality product development. This role is responsible for the governance, definition, and continuous improvement of the organization’s assay requirements‑matter 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.

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.

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

External: Regulatory agencies, Notified Bodies

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