Senior Quality Analyst

vor 2 Monaten


Feldkirchen, Deutschland Danaher Vollzeit

Wondering what’s within BeckmanCoulter Diagnostics? Take a closerlook.


At firstglance, you’ll see that for more than 80 years we’ve been dedicatedto advancing and optimizing the laboratory to move science andhealthcare forward. Join a team where you can be heard, besupported, and always be yourself. We’re building a culture thatcelebrates backgrounds, experiences, and perspectives of all ourassociates. Look again and you’ll see we are invested in you,providing the opportunity to build a meaningful career, becreative, and try new things with the support you need to besuccessful.


Beckman CoulterDiagnostics is proud to work alongside a community of six fellowDiagnostics Companies at Danaher. Together, we’re working at thepace of change to improve patient lives with diagnostic tools thataddress the world’s biggest healthchallenges. 

As aSenior Quality Analyst for Beckman CoulterDiagnostics you will be responsible for Quality Managementresponsibilities that drive significant impact to the organization.You will report to the Senior Manager responsible for QualitySystems management.

This position is part of theQuality Systems department located in Munich, Germany withflexible, hybrid workingarrangements.


If you thrivein a multifunctional environment and Quality Management role andwant to work to build a world-class Quality organization—readon
 

Inthis role, you will have the opportunity to:

QualitySystem ManagementSupport:

  • Supportthe QSMR management – planning, organization and documentation,QSMR action tracking
  • Support the External AuditManagement – planning, real-time audits, post-auditactivities
  • Responsible for Quality Systemstopics such as, responding to audit findings, QMS documentreviews

CAPAManagement:

  • Responsiblefor CAPA activities to problem statements, root cause analysis,corrective and preventative actions, tracking of time lines, andestablishing CAPA files.
  • Monitor theeffectiveness of the CAPAsystem.
  • Support or Conducttraining on tool usage SMARTSOLVE, EDMS,MasterControl


The essential requirements of the jobinclude:

  • Bachelorsor Master´s degree in Engineering / Sciencefield
  • Over 6 years of experience in QualityManagement Systems in a Pharma or Medical Deviceindustry
  • Knowledge of ISO 13485, IVDR, 21 CFRPart 820 and 11
  • Excellent Quality Documentationskills (Good Documentation Practices)
  • Abilityto work independently
  • English Mandatory, Germanis beneficial


It would be a plus if you also possessprevious experiencein:

  • ElectronicDocumentation Management (GxP Tools, MSoffice)
  • Exposure to Certification body / FDAaudits

At Danaherwe bring together science, technology and operational capabilitiesto accelerate the real-life impact of tomorrow’s science andtechnology. We partner with customers across the globe to help themsolve their most complex challenges, architecting solutions thatbring the power of science to life. Our global teams are pioneeringwhat’s next across Life Sciences, Diagnostics, Biotechnology andbeyond. 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.


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