Quality Engineer

Danaher Corporation; Wrexham; On-site; GBP 45,000 - 60,000; Full time

Job summary

Cytiva, part of Danaher Corporation, seeks a Quality Engineer to drive quality adherence and risk assessment in a high-volume manufacturing environment. This on-site role reports to the Quality Engineering Manager in Newquay and will partner with QA specialists and operations teams.

You’ll manage non-conformances, lead investigations, and support continuous improvement initiatives, ensuring processes stay aligned with customer needs and standards.

Qualifications

• Experience with ISO 9001 and ISO13485 within pharmaceutical or similar regulated manufacturing.
• Knowledge of quality assurance and quality control systems.
• Lean or DBS methods training is advantageous.

Responsibilities

• Drive quality adherence and manage process change in high volume manufacturing.
• Report non-conformances, support investigations and closure activities.
• Lead and collaborate on CAPA, root cause analysis and effectiveness reviews.
• Coordinate internal / supplier process improvements to reduce non-conformances.
• Analyze rejects and QC data to establish improvement priorities.
• Support audits and provide quality insights from data analysis.

Skills

Quality management

Regulated environment

Data analysis SPC

Education

Engineering degree

Tools

Danaher System 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

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 .