Supplier Quality Engineer
vor 3 Monaten
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 Supplier Quality Engineer (m/f/d) for Cytiva is responsible to manage supplier defects, be complaint and maintain our Quality Management System processes and records as well as drive improvement to our core value driver, External PPM Defects.
This position is part of the Bioprocess Filtration Supplier Quality Team located in Bad Kreuznach and will be onsite. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.
What you will do:
Supplier qualification, including supplier process qualification (SPQ) for Type I (critical) supplier.
Manage the supplier corrective actions process (SCAR) and supplier change requests (SCR).
Provide input and conducting supplier audits as on approved supplier audit schedule.
Develop and execute Corrective and Preventive Action plans with suppliers to resolve non-conformance issues (QE Complaints and Deviations).
Ensure supplier compliance to QMS and regulatory requirements through supplier monitoring process.
Who you are:
Bachelor’s degree in applicable field (e.g. mechanical engineering, chemical engineering or general life sciences) or equivalent by experience in Quality in a similar BU/Industry.
Minimum 3 years of Quality experience.
Experience with supplier communication and supplier auditing.
Demonstrated knowledge of Quality Management System (ISO 9001 or equivalent), cGMP, continuous improvement methodologies, and Manufacturing Process Control (MPC)
Effective problem solver with the skills to lead Root Cause investigations / CAPA plans and influence others cross-functionally.
Fluent in Englisch and good in German (min. B2 level)
Travel, Motor Vehicle Record & Physical/Environment Requirements:
Ability to travel – 15 - 20% for supplier audits and GEMBA walks.
It would be a plus if you also possess previous experience in:
Medical Device, ISO 13485
Pharmaceutical
Automotive, IATF 16949
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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