Quality Engineering Optimisation Manager

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 wherever they are needed most – from hospital to lab to clinic.

As the Quality Engineering Optimisation Manager, you will provide direction and operational oversight across Quality Engineering, ensuring alignment with global regulatory requirements (ISO
13485, FDA
21CF
R820, IVDR, and other applicable standards). You will lead and develop a team of Quality Engineers focused on continuous improvement and optimisation of manufacturing and quality processes for in vitro diagnostic (IVD) medical devices. The role ensures robust implementation of Corrective and Preventive Actions (CAPA), validation activities, and process improvement initiatives to maintain compliance with regulatory requirements while improving product quality, operational efficiency, and reliability.

• Lead, develop, and inspire a team of Quality professionals to achieve organizational and individual performance objectives.
• Establish clear priorities, assign responsibilities, and ensure effective resource allocation to meet business and compliance needs.
• Coach and mentor emerging Quality leaders and technical experts to build organizational capability and ensure robust succession planning.
• Model Quidel Ortho’s leadership principles by demonstrating collaboration, accountability, inclusion, and service mindset in all interactions.

• Provide technical, regulatory, and operational leadership to ensure Quality systems comply with ISO
  13485, FDA
  21CF
  R820, IVDR, and other applicable requirements.
• Partner with Manufacturing, R&D, Regulatory Affairs, Supply Chain, and other stakeholders to integrate Quality and Compliance principles throughout the product lifecycle as applicable.
• Ensure the team maintains a state of inspection readiness and supports successful engagement with regulatory agencies, notified bodies, and internal audits.
• Provide CAPA management within scope ensuring timely, effective investigation and resolution of quality issues.
• Ensure robust root cause analysis using appropriate methodologies (e.g., 5
  
  Whys, Fishbone, FMEA) and that sustainable corrective and preventive actions are implemented.
• Provide quality support and leadership for process, equipment, and facility changes including validation support, ensuring validation strategies meet regulatory requirements and industry best practices.

• Support harmonization and standardization of Quality processes, procedures, and tools across sites and functions to strengthen compliance and efficiency.
• Promote a culture of continuous improvement by identifying opportunities for simplification, process excellence, and digital enablement within the Quality Management System (QMS).
• Monitor Quality performance using metrics and data analytics to identify risks, drive root cause analysis, and implement sustainable improvements.

• Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline.
• Demonstrated experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries, including experience leading and developing teams.
• Understanding of Quality System regulations and standards, including ISO
  13485, FDA
  21CF
  R820, and IVDR.
• Proven ability to lead and develop high‑performing teams and build future technical and people leaders.
• 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.
• Experience leading in a matrixed,…