Quality Assurance Engineer

Posted 3 Days Ago
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Grens, Vaud
3-5 Years Experience
Biotech
The Role
The Quality Assurance Engineer at Cytiva is responsible for supporting and maintaining compliance records, leading improvement development of QMS, monitoring quality KPIs, and ensuring effective communication with stakeholders. The role requires a minimum of 3 years of experience in Quality Assurance/Quality Engineering within the Life Science, Medical Device, or Biopharma manufacturing environments.
Summary Generated by Built In

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 for Cytiva is responsible for being the voice of Quality supporting and maintaining compliance records under the ownership of operation/engineering functions.

This position is part of the Quality Assurance department located at our Signy Facility (Grens, VD) and will be an on-site position. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.

What you will do:

  • Acts a Quality specialist to Support Operation/engineering functions ((i.e. R&D, Supply Chain, QC, Logistics, Supplier Quality) for investigation on quality issues and to ensure processes meet the requirements of customers, global and local QMS and product quality.

  • Leading improvements development of the QMS, QA processes and QA support function/organization.

  • Accountable for monitoring Quality KPI's including, reporting on performance/ trend insights within Quality boards and business reviews.

  • Ensure effective communication style with stakeholders and establish cross functional operating mechanism.

Who you are:

  • Minimum, Bachelor's degree, preferably in a Science or Engineering field.

  • Minimum 3 years experience of Quality Assurance/Quality Engineering within Life Science, Medical Device or Biopharma manufacturing environments.

  • Comprehensive understanding of ISO 9001 requirements. Understanding of GMP requirements, desired.

  • Analytical, problem solving & root-cause analysis skills.

  • Excellent communication skills (written and oral), fluent in both French & English.

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

  • Continuous improvement methodologies & tools.

  • Transfer of Work and Application of production and process controls including process validation, process control plans and statistical process control.

#Li-onsite

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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