QA Compliance Specialist

Posted 18 Days Ago
Be an Early Applicant
Medemblik, NLD
In-Office
Mid level
Biotech
The Role
The QA Compliance Specialist leads customer audits, manages quality systems, tracks compliance metrics, and oversees product certifications, ensuring adherence to quality standards.
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 QA Compliance Specialist  for Cytiva is responsible for leading Customer Audits, handling all Quality Systems questionnaires and responsible for the local Quality System in our global document management system.

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

In this role, you will have the opportunity to:

  • In this role you will be leading the Customer Audits, handling all Quality Systems questionnaires and responsible for the local Quality System in our global document management system.  Your main areas of responsibility are divided in approximately 30% customer audits and 70% Quality Systems activities.
  • The QA Compliance Specialist is keeping oversight of quality compliance activities (internal and external) and managing the metrics and KPI related to this.
  • The QA Compliance Specialist maintaining the overview of the certified state of products, processes, methods and equipment. He / She is handling deviations of any kind.
  • The QA Compliance Specialist is the Quality Lead in plant wide compliance projects

The essential requirements of the job include

  • Degree: Master in a scientific field, preferable in Lifesciences (bio, biomedical, chemical, pharma,…)
  • Experience: 3+ years
  • Language: English (written & spoken), Dutch
  • Strong working knowledge of quality assurance principles and practices, industry and international regulations and standard, you are familiar with ISO9001 and ISO13485,
  • Strong verbal and communications skills, Ability to multitask, problem solve and decision making
  • Able to use customer feedback to make improvements in process, products and service

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

  • Customer communication
  • Internal and or externa audits
  • QMS

At Cytiva we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cytiva can provide.

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.

Top Skills

Iso13485
Iso9001
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The Company
HQ: Sunnyvale, CA
4,883 Employees
Year Founded: 1996

What We Do

Cepheid is dedicated to improving healthcare by pioneering molecular diagnostics that combine speed, accuracy, and flexibility. The company's GeneXpert® systems and Xpert® tests automate highly complex and time-consuming manual procedures, providing A Better Way for institutions of any size to perform world-class PCR testing. Cepheid’s broad test portfolio spans respiratory infections, blood virology, women’s and sexual health, TB and emerging infectious diseases, healthcare-associated infectious diseases, oncology and human genetics. The company’s solutions deliver actionable results where they are needed most – from central laboratories and hospitals to near-patient settings. For more information, visit http://www.cepheid.com.

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