Quality Engineering Team Manager

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

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career. Learn about the Danaher Business System which makes everything possible.

What you'll do:

• 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

Who you are:

• Degree or equivalent in Scientific, Engineering or Quality discipline (or equivalent working experience)
• At least 5 years experience of managing teams of professionals working in a manufacturing based quality environment
• At least 5 years experience in a relevant Quality Engineering role (e.g. pharma, med device, automotive, aerospace), where compliance in a fast paced business is critical
• At least an advanced level of operating within an ISO9001 environment and knowledge of ISO13485, 21CFR820, GxP and Pharma regulations would be advantageous
• Experience of writing problem statements and executing best practice in CAPA
• Demonstrative experience of using ISO14971 risk management principles and application
• Experienced in deploying strategy and setting and delivering objectives within a team

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com. Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact. Please read our Applicant Data Privacy Notice carefully here.