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Quality Audit Manager Medical (m/f) Job ID: 10633

Disziplin
Quality/Production
Stellenart
Vollzeit
Unternehmen

Our client is a global leader in wound care & related vascular diseases, lymphology and non-invasive orthopaedic products. The company aims to provide an integrated therapy-driven approach – grounded in a broad portfolio of products, enhanced by insights into current therapeutic areas and complemented by a progressive approach to partnerships.

Ihre Aufgaben

 

  • Develop and deploy QM strategies to establish quality compliance to all domestic and international legal and regulatory requirements (“Inspection Readiness”)
  • Develop and establish quality compliance metrics, set appropriate compliance targets, add to the monthly BSC reporting and drive accountability for compliance in all functions and production sites
  • Responsible for the proactive identification and alerting of management of quality issues in time to resolve potential adverse effects to the customer / patient, company image / reputation and / or business
  • Routinely audit plants and business to monitor
  • Support the preparation and execution of major external audits / inspections (e.g. FDA)
  • Responsible for the written response of the audited / inspection site to audit / inspection reports. Safeguarding of adequate and timely completion of relevant audit and inspection obligations like corrective and preventative actions
  • Regular reporting of auditing process related metrics
  • Continuously improve the quality compliance program under value-add and economical aspects

 

Ihr Anforderungsprofil

 

  • 3-5 years experience in quality assurance / quality management at medical device manufacturers or pharmaceutical companies (in management positions)
  • Experienced and certified (lead) auditor
  • Strong knowledge on quality system standards, laws and regulations such as ISO 13485, ISO 14971, FDA QSRs, EU Medical Device regulations / directives, GxPs etc.
  • Strong knowledge on and application of modern QM techniques like (lean) Six Sigma
  • Excellent communication and influencing skills
  • Ability to work across all levels of the organization
  • Demonstrated ability to work in a matrixed environment
  • Engineering or Life Science related bachelor’s degree
  • Fluent in German and English (verbal and written)

 

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Eintrittstermin
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Ansprechpartner
Michael Meyer
Fon +49 89 416 11 70 - 0
Mobil +49 152 336 690 48
Ansprechpartner
Michael Meyer
Fon +49 89 416 11 70 - 0
Mobile +49 152 336 690 48
Mail michael.meyer@theentourage.de
Betreff Bewerbung für Job ID 10633 auf theentourage.de