Quality Engineer

Posted 6 Days Ago
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Ilfracombe, North Devon, Devon, England
3-5 Years Experience
Biotech
The Role
Quality Engineer role at Cytiva, a Life Sciences company under Danaher. Responsibilities include driving continuous improvement in quality culture, leading problem-solving teams, providing support for QE technicians, contributing to risk assessment, and ensuring QARA compliance. Requires a recognized engineering qualification and a minimum of 3 years' experience in a Quality Engineering role in a fast-paced manufacturing environment.
Summary Generated by Built In

Be part of something altogether life-changing!

Working at Cytiva in the Life Sciences industry 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. With associates across 40 countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.

Cytiva is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

What you’ll do:

  • Champion Danaher Business System and drive continuous improvement to the Quality culture
  • Lead/support problem solving teams to define scope and problem statement of systemic issues. Drive to root cause using pareto, 5Y, Ishikawa and other appropriate quality, statistical and lean tools and ensure effective corrective actions implemented.
  • Provide support and advice to QE technicians and stakeholders carrying out investigation and destructive analysis of customer complaint samples. Analysis of complaint root causes and data trending to identify and initiate problem solving and improvement activities.
  • Support operations with “Voice of the process” and investigation of internal non-conformities. Act as initial point of contact for supplier related issues, liaising between manufacturing and supplier quality/engineering functions
  • Provide QA support and approval for product and process validation (FAT/SAT, IQ/OQ/PQ) and change control
  • Contribute to cross functional risk assessment/preventive action techniques including FMEA.
  • Carry out quality review of key documents and investigations to support timely delivery.
  • Support QARA Compliance and audit team in delivery of QMS ISO9001 and corporate requirements

Who you are:

  • Recognised engineering or related qualification (HNC/HND/Degree) or equivalent experience
  • Minimum 3 years’ experience in a Quality Engineering role, within a fast-paced manufacturing environment, ideally Life Science, Medical Device or Biopharm
  • Experience using quality techniques & statistical analysis tools - Pareto, 5Y, 8D, fishbone/Ishikawa, process mapping, FMEA, process capability, DoE, FMEA
  • Able to communicate effectively at all levels, both internally and externally to the business
  • Experienced in managing project teams and working cross functionally, both locally & globally.
  • Excellent organizational, presentation and meeting facilitation skills

    At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

    At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

    The Company
    Marlborough, MA
    8,399 Employees
    On-site Workplace

    What We Do

    Cytiva, now with the life sciences business from Pall Corporation, is a global life sciences leader dedicated to helping customers discover and commercialize the next generation of therapeutics. Together, we bring dedicated technical expertise and a broad portfolio of tools and technologies that enable the development, manufacture, and delivery of transformative medicines to patients.

    Visit cytiva.com to learn more.

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