Job Title: Senior Manager, Quality Assurance
Salary: £55,000 – £60,000 DOE
Location: Nottinghamshire, UK
Job Type: Permanent
Our client is seeking an accomplished Senior Quality Assurance Manager to join their team and take responsibility for the site Quality Management System. This is an exciting opportunity for a proven professional who thrives in highly regulated environments and wants to make a real impact on global healthcare. In this role, you’ll lead audits and inspections, guide cross-functional teams, and drive continuous improvement initiatives, all while ensuring compliance with international standards.
Key Responsibilities:
- Lead the site Quality Management System in compliance with ISO 13485, FDA, EU, UK MDR, and other applicable global regulations; serve as the site Quality Management Representative.
- Manage and develop the Quality Assurance team, overseeing audits, inspections, product registrations, certifications, and supplier quality activities.
- Drive continuous product and process improvements using data-driven methodologies (Six Sigma, Lean, DOE, FMEA, Gage R&R) and ensure effective nonconformance management and corrective actions.
- Support new product development and launches by ensuring quality, performance, and regulatory compliance, while also overseeing labeling, claims, and global regulatory submissions.
- Monitor evolving domestic and international regulations, provide proactive compliance strategies, and manage departmental budgets, performance reviews, and team development.
Experience and Qualifications Required:
- 7-10 years Quality Assurance experience
- Proven leadership skills with the ability to motivate teams, drive performance, and manage change through Lean and Six Sigma principles.
- Direct experience interacting with regulatory agencies (FDA, MHRA, Notified Bodies, and others), including leading audits, inspections, and securing licenses and registrations.
- Excellent communication skills (written and verbal), with the ability to collaborate across functions, manage large-scale projects, and work effectively in both in-person and virtual environments.
How to apply: Apply to e.smailes@x4lifesciences.com to learn more about the role or connect with me on LinkedIn to hear about regular job updates available with X4 Life Sciences.
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