Quality Improver

Role overview

Working hours

• Full-time role, 5 days per week, 37.5 hours, Monday to Friday.

Investigations and improvement

• Represent QA in NCR, Quality Feedback, customer complaint, and SNC investigations; perform root cause analysis and train others.
• Monitor investigation completion time, prepare reports, lead meetings, and evaluate corrective and preventive action effectiveness.
• Lead and participate in quality improvement projects; develop project documentation and training materials and provide training.

Risk, changes, and CAPA

• Act as risk assessment lead, team member, and Quality subject matter expert.
• Lead and analyze engineering change orders and support Engineering and the wider business with changes.
• Identify corrections and corrective and preventive actions in CAPA teams and support timely investigation and implementation.

Quality systems and documentation

• Review quality process metrics and trends, including NCRs, customer complaints, quality feedback, and SNCs.
• Provide GMP training and represent QA in GMP improvement projects.
• Write technical reports, approve engineering studies, and create procedures and work instructions.

Experience and qualifications

• At least 1 year of experience in a regulated industry.
• Knowledge of quality improvement tools and processes and experience applying ISO 14971 risk management for medical devices.
• Computer literacy and knowledge of GPS, Baan, Red Prairie, Agile, and Microsoft packages.
• Full, current driving licence and flexibility to work across UK sites.
• Knowledge of contact lens and packaging and distribution processes.
• Experience in Quality or Engineering is an advantage; ISO 13485 knowledge is beneficial.
• Strong written and verbal communication, organization, workload prioritization, and ability to work independently or in a team.

Benefits and development

• Benefits include 25 days of holiday, pension, healthcare cover, life assurance, wellness support, and a discounted contact lens scheme.
• The employer offers training and LinkedIn Learning for professional development.