Quality Lead, and Specifications Management; Assay

Overview

Quidel Ortho 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 Quality Lead, Requirements and Specifications Management (Assay) is a global individual contributor within Quidel Ortho’s Global Quality & Compliance (GQ&C) organization. The 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. The position is onsite in Rochester, NY.

• 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.

• 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.

• 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.