Quality Assurance Engineer

vor 3 Monaten

Kelsterbach, Deutschland Cytiva Vollzeit

Be part of something altogether life-changing

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. 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.

Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.

The Quality Assurance Engineer (m/f/d) for Cytiva is responsible for maintaining and improving the Quality Management System by ensuring Cytiva, Customer, and Regulatory requirements are being met through project execution and delivery of product. This includes management of quality performance targets including customer complaints and nonconformance investigations.

This position is part of the Quality Assurance Custom HW department located in Dreieich and will be on-site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.

What you will do:

  • Complaints management:

    • Responsible for receiving, analyzing, documenting, and responding to customer complaints in a timely manner.

    • Perform complaint trend analysis on regular basis to be used at operational reviews, Management Reviews and Complaint Handling Unit (CHU) meetings

  • Nonconformity and CAPA management:

    • Manage Non-conformance and CAPA (internal and external) processes; ensure root cause analysis and effectively implement robust action plans. Follow-up and verification of CAPAs to ensure no recurrence. Facilitate the closures of these in a timely manner.

  • Internal auditing

  • Monitor QA KPIs and escalate trends and ensuring that continuous improvement activities such as PSPs, CAPAs are raised as countermeasures.

Who you are:

  • Bachelor’s degree in engineering discipline (e.g. mechanical or chemical engineering).

  • Minimum 2-3 years of experience in Quality role, preferably in the Life Sciences industry.

  • Good knowledge of using MS Office tools such as MS Excel to perform analytics and data management.

  • Ability to communicate effectively in both German and English (written and spoken).

It would be a plus if you also possess previous experience in:

  • Knowledge and awareness of the methods and techniques of Quality Control in the manufacturing industry.

  • Technical knowledge of systems/devices used in the biopharma field.

  • ISO 9001

Benefits

  • Attractive salary

  • Numerous benefits such as company pension scheme, accident insurance

  • Development opportunities at Cytiva and within the Danaher Group

  • International corporate environment in a rapidly growing industry

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.

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