Quality Engineer

Radiometer; Newquay; On-site; GBP 45,000 - 65,000; Full time

Job summary

Cytiva in Newquay is seeking a Quality Engineer to drive quality adherence, process change and risk assessment in a high-volume manufacturing facility, on-site.

You will lead investigations, support operations teams, trend data, and ensure inspections align with customer needs, while contributing to CAPA and Continuous Improvement initiatives within the Danaher ecosystem.

Experience in ISO 9001/13485 and DBS tools is valued; a relevant engineering degree is required.

Qualifications

• Experience in ISO 9001 / ISO13485 regulated manufacturing environments.
• Knowledge of quality systems in regulated manufacturing.
• Experience with SPC and Lean methods.
• Quality accreditation or certification with an engineering degree.
• PSP practitioner preferred.

Responsibilities

• Drive quality adherence and risk assessment in a high-volume manufacturing environment.
• Support non-conformances and investigations, ensuring closure.
• Lead improvements through data analysis and SPC to reduce non-conformances.
• Coordinate CAPA and verify effectiveness of actions.
• Support audits and external validations as required.

Skills

ISO 9001 experience

ISO13485 experience

SPC

Danaher Business System

Quality Assurance

Quality Control

Lean

PSP practitioner

Education

Engineering degree

Tools

Danaher DBS tools

SPC

Job description

The Quality Engineer for Cytiva is responsible for driving quality adherence, process change and risk assessment in a high volume manufacturing facility. This position is part of the Quality Engineering Team reporting to the Quality Engineering Manager located in Newquay and will be an on‑site position.

What you'll do:

• Facilitate Compliance improvement within the Value Stream
• Ensure non-conformances are reported when they occur, support associated investigations, and facilitate non-conformance closure.
• Actively review the production environment identifying non-conformity, areas to improve compliance
• Coordination and reporting of relevant failure investigations and subsequent corrective and preventive actions and reviewing effectiveness of these.
• Support and lead the operations teams and Engineers when required in the evaluation, trending and reporting of internal and external non-conformances to establish priorities and identify common threads aimed at a continuous reduction in internal non-conformance occurrences via internal or supplier process improvements.
• Work with the Engineers to collect, analyse, trend and report data on rejects from routine production inspection and QC tests and related processes to establish improvement priorities and identify common threads aimed at a reduction in external complaints.
• Work with QA Specialists and others as appropriate to ensure that production inspections and QC tests are aligned with customer needs.
• Provide a Quality insight into the results and conclusion of data analyses and trending.
• Ensure required processes, practices and standards in production, quality control and related areas are validated, and continuously improved working with unit managers, manufacturing engineers and team leaders to achieve this.
• Keep abreast of the development of standards to ensure techniques and practices are kept up to date; recommend internal OMS/procedure changes as required
• Support product development/transfer activities.
• Review and develop procedures relevant to departmental operations.
• Provide support to Quality Assurance Manager during external audits of Pall Newquay.
• Manage complaint investigations identifying improvement opportunities.
• Lead CDTR projects to completion.
• Support Cost reduction programs and lead projects where appropriate
• Actively identify improvement opportunities and facilitate their implementation.
• Support daily Management processes to facilitate the use of best practice

Who you are:

• Experience of working within an ISO 9001 / ISO13485 / Pharma regulated manufacturing environment.
• Knowledge of systems adopted within a regulated Manufacturing facility.
• Background knowledge of Quality Assurance and Quality Control Systems.
• Experience in the use of Danaher Business System tools and the use of SPC.
• Possess Quality accreditation or certification with the relevant or a recognised Engineering Degree and subsequent experience.
• Formal training and qualification in Lean or DBS techniques would be an advantage.
• PSP practitioner

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.

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