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QUALITY & COMPLIANCE MANAGER EMEA (M/F)

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Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and established pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 77,000 people.

In Germany, Abbott has approximately 2,600 employees working in manufacturing, research and development, logistics, sales and marketing. They are located at Abbott`s German headquarters in Wiesbaden and its sites in Ettlingen, Hanover, Ludwigshafen, Neustadt am Rübenberge, Wetzlar and Witten.

Abbott Point of Care (APOC) is looking for a Compliance Professional Commercial EMEA (m/f) based in our office in Wiesbaden (Germany).

Compliance Professional EMEA (m/f)

1500000EEK

Job Responsibilities:

  • Responsible for implementing and maintaining the effectiveness of the quality system
  • Monitor complaint handling activities across affiliates within the area to establish consistency in application.
  • Serve as communication link between QS of commercial affiliates and division management
  • Perform and follow-up on audits in Commercial affiliates within the area on Commercial Affiliate QS which also includes complaint handling
  • Perform timely and complete complaint ticket reviews within the area according to divisional requirements
  • Maintain all records of reviewed tickets
  • Maintain compliance to FDA/ISO and division requirements for complaint handling
  • Report or elevate systemic findings through area and division management
  • Seek opportunities to continuously improve understanding, performance and quality of complaint documentation, processes and procedures
  • Support affiliates to ensure area wide compliance to division policies and procedures
  • Support affiliates with implementation and follow-up of corrective and preventive actions as a result of the commercial affiliate audits

Qualifications

  • Bachelor’s Degree: B.S. or B.A.. in Medical Technology or related scientific field
  • Knowledge of regulations and standards affecting IVDs and Biologics
  • Technical / Scientific background, must be able to demonstrate ability to understand underlying technical principles in order to effectively apply QSR/ISO regulations on complaint handling in a very technical environment
  • Experience in complaint handling, customer support and/or auditing techniques
  • Fluent in English (oral and written)
  • Self motivator
  • Motivates and inspires others
  • Strong communication and presentations skills
  • Successful in error resolution and conflict management
  • Experience in MS Office
  • Ability to travel; up to 25% of travel required
  • Motivated and able to work independently
  • Results-oriented
  • Flexible and open to changes

Abbott Germany has a range and variety of jobs on offer in a positive and dynamic environment that allows you to maintain a healthy work-life balance. We provide a variety of development opportunities as part of our comprehensive Talent Management Program. Your contribution to the company’s success will be rewarded with a competitive salary package. We offer comprehensive benefits to suit the lifestyles of all our employees, from a retirement plan that is far above market average, a save-as-you-earn program, to educational scholarships for children, and health management initiatives for staff and their dependents.

Abbott is a truly diverse and global company. We are an equal opportunity employer and welcome applications from all candidates.

Do you like the sound of this job and think you’ve got what it takes? Then send us your CV today via our Global Job Board. We look forward to receiving your application.

Compliance Professional Commercial EMEA Qualitätsmanagement Beschwerdemanagement Kundenbetreuung Auditing Reporting Konfliktmanagement Qualitätswesen Produktqualität Risikomanagement Konfliktmanagement Produktsicherheit Zulassungsverfahren Zulassung Qualität Regulatory Affairs Qualitätsmanager Qualitätssicherung QSR ISO Medizintechniker Medizintechnikerin Bachelor of Science Pharmazeut Pharazeutin Techniker Technikerin Health Care Biologe Biologin Chemiker Chemikerin IVD Biologie Reisebereitschaft Dienstreisen Kompliance Regeltreue Regelkonformität Medizintechnik Pharmabranche Pharmaindustrie Gesundheit Medikamente Arzneimittel Health Care Abbott GmbH Wiesbaden 65205 Hessen ax49912by
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