Global Quality Lead: Assay Requirements & Specs

Ortho Clinical Diagnostics; Bridgend; On-site; GBP 101,000 - 131,000; Full time

Benefits offered by this job

Medical benefits

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) with ESPP

Paid time off

Employee Assistance Program

Job summary

QuidelOrtho in the United Kingdom seeks a Quality Lead, Requirements and Specifications Management (Assay) to drive end-to-end quality for assay-based medical devices. You will own the design inputs, enable compliant, scalable product development, and partner with R&D, Regulatory Affairs, Manufacturing, and Product Management.

The role requires 7+ years in Quality/Compliance within medical devices, ISO 13485 and FDA/IVDR knowledge, and a proven ability to lead cross-functional initiatives.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related discipline.
• 7+ years of progressive experience in Quality, Compliance, or related fields within Medical Device/IVD/Biopharma.
• Strong understanding of ISO 13485, FDA 21 CFR 820, IVDR and related quality systems.
• Proven success driving quality initiatives aligned with business strategy and regulatory expectations.
• Excellent collaboration, influence, and communication across functions.
• Strong analytical and problem-solving skills with data-driven approaches.
• Commitment to scientific integrity and continuous improvement.

Responsibilities

• Establish clear quality priorities, assign responsibilities, and allocate resources for compliance.
• Provide leadership to ensure Quality systems comply with relevant regulations and standards.
• Drive harmonization of processes and tools across sites to strengthen compliance and efficiency.
• Partner with Manufacturing, R&D, Regulatory Affairs, and Supply Chain to embed quality principles throughout product lifecycle.
• Promote continuous improvement and digital enablement within the QMS.
• Ensure inspection readiness and support regulatory audits and Notified Bodies.
• Monitor quality performance with metrics and data analytics to drive improvements.
• Coach and mentor quality team members and support succession planning.
• Communicate strategy, progress, and risk mitigation to senior leadership and stakeholders.
• Perform other duties as assigned.

Skills

Collaboration

Analytical thinking

Data-driven decision-making

Regulatory knowledge

Communication skills

Education

Bachelor's degree in Life Sciences or Engineering

Advanced degree (MS, PhD, MBA) preferred

Job description

QuidelOrtho in the United Kingdom seeks a Quality Lead, Requirements and Specifications Management (Assay) to drive end-to-end quality for assay-based medical devices. You will own the design inputs, enable compliant, scalable product development, and partner with R&D, Regulatory Affairs, Manufacturing, and Product Management.

The role requires 7+ years in Quality/Compliance within medical devices, ISO 13485 and FDA/IVDR knowledge, and a proven ability to lead cross-functional initiatives.