1+ months

Senior Supplier QA Auditor

New York, NY 10017

At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

In Germany, Abbott has more than 3,000 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 Hanover, Neustadt am Rübenberge, Wetzlar, Eschborn and Witten. Alere in Cologne and Jena is now Abbott.

Abbott Diagnostics Division (ADD) is looking for a

Manager Supplier QA Auditor (w/m/d) home-based

field based out of any European country in which Abbott has an affiliate such as e.g. Germany, Italy, UK, Czech Republic, The Netherlands, Spain.

Independently conducts assigned audits of Suppliers and Third Party Manufacturers (TPM) to assess compliance to all applicable External Standards and Regulations as well as Abbott Quality System requirements at a standard commensurate with regulatory external audits. May participate in audits of manufacturing and commercial affiliate sites; involved in projects that are cross-functional/cross-divisional in scope as Subject-Matter-Expert (SME).

Future career trajectory (3-5 years) possibilities would include roles such as Manager and/or  Director of Internal Audit Program, Supply Chain Quality Assurance

Main Responsibilities:
  • Responsible for implementing and maintaining the effectiveness of the quality system
  • Independently conducts and leads audits across ADD's Supplier and TPM network
  • Identifies compliance risks to current standards / regulations and may guide in the planning and execution of Quality System improvements
  • Ensures compliance to Division and Corporate policies and procedures by promptly reporting non-compliance issues
  • Provides guidance and trains colleagues; provides oversight to one or more junior level auditors
  • Participates as SME in audits; provides compliant; and strategic solutions to complex quality issues
  • Leads projects that are cross-functional in scope; directly influences project direction and scope; champions new initiatives and acts as the catalyst for change within and potentially across Divisions
  • Maintains and demonstrates understanding of global standards; regulations and regulatory bodies
  • May assume managerial responsibilities as needed

    Minimum Education

    Apprenticeship or Bachelor's degree in Life Science; Engineering or closely related discipline is required. Experience in the medical device / pharmaceutical industry.

    Minimum Experience / Training Required
    • Knowledge of Good Manufacturing Practices (GMPs), Quality System standards and regulatory requirements such as 21 CFR 820; ISO 13485; IVDD; etc.
    • Trained in auditing techniques; Certified Auditor qualification or equivalent is required.
    • Excellent written and verbal communication skills
    • Fluent English and add. European Languages are a plus
    • Travel time 35-40% in Europe, Asia and Latin America

      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 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.

      Do you like the sound of this job and think you’ve got what it takes? Then send us your CV today. We look forward to receiving your application.
      Job Family: Operations Quality
      Division: ADD Diagnostics
      Additional Location: Germany - Berlin
      Travel: Yes, 25 % of the Time
      Medical Surveillance: Not Applicable
      Significant Work Activities: Not Applicable


Posted: 2018-05-23 Expires: 2018-12-28

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Senior Supplier QA Auditor

New York, NY 10017

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