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Quality Management System Specialist (f/m/d)

Location
Böblingen, Baden-Württemberg
Job Type
Permanent
Posted
21 Sep 2022
Wir suchen:Quality Management System Specialist (f/m/d)Time for change - time for a new job! You are a Quality Management System Specialist and looking for a new professional challenge? Then stop searching! We offer the job you are looking for: Our subsidiary GULP solution services offers a secure job, fair compensation and exciting new tasks at an attractive Medical Technology company in Böblingen. Apply online now! We welcome applications from all suitably qualified persons regardless of any disabilities.Das bieten wir Ihnen
  • Option of permanent employment with our business partner
  • Extensive social benefits, incl. Christmas and holiday bonuses
  • Up to 30 days vacation per year
  • Free online courses, "German as a foreign language"
Ihre Aufgaben
  • Ensure compliant and effective QMS's are maintained in scope; support standardization of MS/QMS processes
  • Key contributor to transformation of all current MS/QMS's; revise processes, review and process change requests
  • Active Change Management and Impact Analysis/Change lead to ensure successful change management site engagement
  • Ensure Document Control is established and ensures training profiles are assigned and enforced and training administration is established; back-up TSA support
  • Ensure Q&R requirements are effective in all processes
  • Quality Management System process expert, acting in support of the local business Heads of Q&R and QMS element owners across the business to deploy standardized processes
  • Support external and internal audit readiness and provides support during external and internal audits
  • Actively participate in Quality & Regulatory initiatives as a cross functional contributor
  • Maintain the QMS while driving QMS transformation locally in support of strategic initiatives including Excellence Process Framework
  • Demonstrate operational excellence and ensure quality in all deliverables
Erfahrungen
  • Bachelor's degree plus several years of related experience in the medical device or another regulated industry
  • Expert understanding of Quality Management System requirements and standards, ISO 9001, ISO 19011, preferably ISO 13485:2016, FDA 21 CFR part 820, EU MDR for medical devices
  • Government/regulatory-body Quality System auditing/inspection experience preferred
  • Excellent computer skills
  • Familiar with process management software, preferably ARIS
  • Familiar with open content management systems, Confluence, Sharepoint, Yammer
  • Project Management skills (development of project plans, status meetings, project reporting, etc.) and process/organizational change management experience
  • Communication in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor
  • Solid organizational and interpersonal skills
  • Ability to analyze information and come to conclusions based on presented data
  • German, English fluent reading and writing skills
  • Residence in Germany
Über Randstad Ein sicherer Job - mit Randstad. Denn wir sind nicht nur Deutschlands führender Personaldienstleister. Vor allem stehen wir für das Versprechen, gemeinsam weiterzukommen. Wir bieten allen Mitarbeitern die Sicherheit von unbefristeten Arbeitsverträgen, Fairness und vielfältige ;So helfen wir Ihnen dabei, Ihr wahres Potenzial auszuschöpfen. Aus Gründen der besseren Lesbarkeit wird bei Personenbezeichnungen und personenbezogenen Hauptwörtern in Randstad Stellenanzeigen die männliche Form verwendet. Entsprechende Begriffe gelten im Sinne der Gleichbehandlung grundsätzlich für alle Geschlechter. Die verkürzte Sprachform hat nur redaktionelle Gründe und beinhaltet keine Wertung. Stellendetails:Referenznummer:C Einsatzort: 71032 Böblingen Baden-Württemberg Deutschland Branche: Medizintechnik Beruf: Qualitätsmanager / Qualitätsmanagerin Tätigkeitsbereich: Qualitätsmanagement (Produkt, Prozess, Kontrolle etc.) Vergütung: - EUR pro Jahr Vertragsart: Festanstellung (Zeitarbeit) Befristung: unbefristet Stellenanzeige teilen:Weitere Stellenanzeigen für Sie:Powered by сompleet GmbH Impressum Datenschutz
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Details

  • Job Reference: 717354257-2
  • Date Posted: 21 September 2022
  • Recruiter: GULP Information Services GmbH
    GULP Information Services GmbH
  • Location: Böblingen, Baden-Württemberg
  • Salary: On Application
  • Sector: I.T. & Communications
  • Job Type: Permanent