Quality Systems and Regulatory Compliance Manager

2 weeks ago

Solna Municipality, Sweden Cepheid Full time

At Cepheid, we are passionate about improving healthcare through fast, accurate diagnostic testing. Our mission drives us to develop scalable, groundbreaking solutions to solve the world's most complex health challenges. As a member of our team, you will be responsible for managing Quality Systems (QS) processes and related deliverables in conjunction with Company objectives and Regulatory requirements.

The role will be part of the Quality Assurance department and will be located in Solna, Stockholm, Sweden. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.

In this role, you will have the opportunity to:

  • Lead and monitor Cepheid AB site audits and Quality system inspections readiness
  • Lead and develop Cepheid Quality System team ensuring Cepheid AB has continuous compliance with the corporate Quality Policies and applicable regulatory requirements
  • Lead the Quality System team to ensure compliant and timely deliverables, such as internal audit program, Quality training program for Cepheid AB, CAPAs, Corrections, etc...
  • Participate to the definition of annual quality goals and quality plans
  • Lead the Quality System Management reviews
  • Monitor Quality key performance indicators and coordinate Problem Solving Plan cross-functional teams where needed
  • Manage CAPA process and ensure compliant and timely deliverables of corrective and preventive actions.

The essential requirements of the job include:

  • University degree in Life Science or related
  • At least five years experience in Quality Assurance, preferably in the diagnostics / medical device industry
  • Excellent skills in written and verbally (English required)
  • Experience of external audits and of working in a global environment
  • Experience or capacity to leading projects or teams

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

  • Qualified Quality System auditor (ISO9001 – ISO13485)
  • Knowledge of risk management standard (ISO14971) and tools (FMEA, FTA etc..)
  • ISO 13485, 21CFR Part820, MDSAP related regulations

Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

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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