Quality Engineering Lead - Life Sciences Impact

Radiometer; Ilfracombe; On-site; GBP 65,000 - 90,000; Full time

Job summary

Cytiva in the United Kingdom seeks a Quality SME to lead the Quality Technician/Engineering team in manufacturing investigations and CAPA actions. You will author and review technical reports, coach staff, and drive cross-functional projects to ensure compliant outcomes.

Role requires a degree in Scientific/Engineering/Quality discipline and at least 5 years in quality leadership within a manufacturing environment, with strong ISO9001 exposure and knowledge of ISO13485, GxP.

Qualifications

• Degree or equivalent in Scientific, Engineering or Quality discipline (or equivalent working experience).
• At least 5 years managing teams in a manufacturing quality environment.
• Minimum 5 years in a Quality Engineering role (pharma/med device) with fast-paced compliance.
• Advanced ISO9001 experience; knowledge of ISO13485, 21CFR820, GxP helpful.
• Experience writing problem statements and CAPA best practices.
• Experience applying ISO14971 risk management principles.
• Experience deploying strategy and setting team objectives.

Responsibilities

• Act as Quality SME and manage daily deployment and priorities of the Quality Technician/Engineering team to support customer and manufacturing complaint investigations and improvement actions
• Author and review technical reports providing feedback and coaching on best practice, enabling associate development
• Provide skills and career path development and guidance to team members
• Work cross functionally with key stakeholder departments such as operations, engineering, supply chain and maintenance to deliver projects, resolve issues and deliver compliant outcomes
• Deploy and embed new procedures and policies ensuring compliance to requirements
• Maintenance, reporting and escalation as necessary of departmental and supporting site KPIs
• Support other functions within the department as necessary

Skills

Quality management

Team leadership

CAPA

ISO9001

ISO13485

GxP

Education

Degree in Science/Engineering/Quality

Tools

CAPA tools

Job description

Cytiva in the United Kingdom seeks a Quality SME to lead the Quality Technician/Engineering team in manufacturing investigations and CAPA actions. You will author and review technical reports, coach staff, and drive cross-functional projects to ensure compliant outcomes.

Role requires a degree in Scientific/Engineering/Quality discipline and at least 5 years in quality leadership within a manufacturing environment, with strong ISO9001 exposure and knowledge of ISO13485, GxP.