Supplier Quality Engineer (m/f/d)

Posted 9 Days Ago
Be an Early Applicant
Bad Kreuznach, Rheinland-Pfalz
3-5 Years Experience
Biotech
The Role
Manage supplier defects, ensure compliance to Quality Management System and regulatory requirements, conduct supplier audits, develop Corrective and Preventive Action plans, and drive supplier improvement.
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 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.

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.

Jobs at Similar Companies

Pfizer Logo Pfizer

Senior Health Representative - Specialty Care

Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Dubai, ARE
121990 Employees

Takeda Logo Takeda

Associate Manager, Clinical Data Validation Engineer

Healthtech • Software • Analytics • Biotech • Pharmaceutical • Manufacturing
Hybrid
Cambridge, MA, USA
50000 Employees
97K-152K Annually

Asimov Logo Asimov

Laboratory Operations Manager

Artificial Intelligence • Machine Learning • Biotech • Design
Easy Apply
Hybrid
Boston, MA, USA
95 Employees

Similar Companies Hiring

Pfizer Thumbnail
Pharmaceutical • Natural Language Processing • Machine Learning • Healthtech • Biotech • Artificial Intelligence
New York, NY
121990 Employees
Takeda Thumbnail
Software • Pharmaceutical • Manufacturing • Healthtech • Biotech • Analytics
Cambridge, MA
50000 Employees
Asimov Thumbnail
Machine Learning • Design • Biotech • Artificial Intelligence
Boston, MA
95 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account