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Quality Assurance Engineer (m/f/d)

Cytiva
Kelsterbach, Hessen, Germany
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Be part of something altogetherlife-changing!

Working atCytiva means being at the forefront of providing new solutions totransform human health. Our incredible customers undertakelife-saving activities ranging from fundamental biological researchto developing innovative vaccines, new medicines, and cell and genetherapies.

At Cytiva you willbe able to continuously improve yourself and us working onchallenges 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 learningopportunity so you can grow your career and expand your skills inthe long term.

Forming part ofthe Biotechnology segment at Danaher, we bring together dedicatedtechnical expertise and talent to develop the next generation oflife-changingtherapeutics.

The Quality Assurance Engineer (m / f / d) for Cytiva isresponsible for maintaining and improving the Quality ManagementSystem by ensuring Cytiva, Customer, and Regulatory requirementsare being met through project execution and delivery of product.

This includes management of quality performance targets includingcustomer complaints and nonconformanceinvestigations.

This positionis part of the Quality Assurance Custom HW department located inDreieich and will be on-site. At Cytiva, our vision is, to advancefuture therapeutics from discovery todelivery.

What youwill do :

Complaintsmanagement :

Responsible forreceiving, analyzing, documenting, and responding to customercomplaints in a timelymanner.

Perform complainttrend analysis on regular basis to be used at operational reviews,Management Reviews and Complaint Handling Unit (CHU)meetings

Nonconformityand CAPA management :

ManageNon-conformance and CAPA (internal and external) processes; ensureroot cause analysis and effectively implement robust action plans.

Follow-up and verification of CAPAs to ensure no recurrence.Facilitate the closures of these in a timelymanner.

Internalauditing

Monitor QA KPIs andescalate trends and ensuring that continuous improvement activitiessuch as PSPs, CAPAs are raised ascountermeasures.

Whoyou are :

Bachelor’sdegree in engineering discipline (e.g. mechanical orchemicalengineering) .

Minimum2-3 years of experience in Quality role, preferably in the LifeSciences industry.

Goodknowledge of using MS Office tools such as MS Excel to performanalytics and datamanagement.

Ability tocommunicate effectively in both German and English (written andspoken).

Itwould be a plus if you also possess previous experiencein :

Knowledge andawareness of the methods and techniques of Quality Control in themanufacturingindustry.

Technicalknowledge of systems / devices used in the biopharmafield.

ISO9001

Benefits

Attractivesalary

Numerousbenefits such as company pension scheme, accidentinsurance

Developmentopportunities at Cytiva and within the DanaherGroup

Internationalcorporate environment in a rapidly growingindustry

AtDanaher we bring together science, technology and operationalcapabilities to accelerate the real-life impact of tomorrow’sscience and technology.

We partner with customers across the globeto help them solve their most complex challenges, architectingsolutions that bring the power of science to life.

Our global teamsare pioneering what’s next across Life Sciences, Diagnostics,Biotechnology and beyond. For more information, visit www.danaher.com .

AtDanaher, we value diversity and the existence of similarities anddifferences, both visible and not, found in our workforce,workplace and throughout the markets we serve.

Our associates,customers and shareholders contribute unique and differentperspectives as a result of these diverseattributes.

Vor 15 Tagen
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