Commercial Quality Specialist EMEA (m/f/d)

Abbott GmbH (Wiesbaden HE, Deutschland) Vor 6 Tagen veröffentlicht

JOB DESCRIPTION:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.

Connect with us at [...] on LinkedIn at [...] on Facebook at [...] on Twitter @AbbottNews and @AbbottGlobal.

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, Witten, Cologne and Jena. Abbott Automation Solutions in Hamburg (formerly GLP Systems) is now Abbott.

Abbott Point of Care: Poised for Growth

Abbott Point of Care (APOC), a $600 million division of Abbott (NYSE: ABT), enables health care professionals to accurately achieve real-time, lab-quality diagnostic results at the point of care within minutes.  Testing at the point of care enables health care professionals to make rapid triage and treatment decisions when diagnosing a patient’s condition or monitoring a treatment response. By simplifying the testing process, clinicians can focus on what matters most—caring for the patient.

Abbott Point of Care’s i-STAT Analyzer is a handheld system that is used with single-use i-STAT test cartridges.  Together they form the i-STAT System*—a blood analysis system that provides health care professionals with the information they need to rapidly make treatment decisions.  Patient bedside testing with the i-STAT System is as easy as inserting two or three drops of blood into the cartridge, inserting the cartridge into the handheld, and then viewing test results in as little as two minutes for most cartridges.  Test results are uploaded automatically—delivered wirelessly with the i-STAT Wireless or directly when the i-STAT handheld is placed in a downloader.  The i-STAT System eliminates process steps and handoffs to help reduce the incidence of errors and promote patient safety.

Hospitals and clinics in more than 100 countries around the world depend on the i-STAT System in critical care situations.  For more information about Abbott Point of Care and the i-STAT System, please visit [...] have an opportunity for a Commercial Quality Specialist (m/f/d) at our EMEA region Headquarters located in Wiesbaden, Germany.

The Commercial Quality Specialist EMEA will support Commercial Quality System management maintenance in EMEA region, with a focus on distributor management. 

Main Responsibilities:

  • Perform the timely audit and approval of distributors as part of the distributor selection, qualification, and approval process.  This includes audit scheduling and execution, complete timely audit reports, and the follow-up or review of distributor corrective actions

  • Prepare, co-ordinate and approve distributor Quality Agreement to ensure robust partnerships exist

  • Communicate and train distributors on APOC quality requirements

  • Identify gaps, communicate any observations noted and review responses so that a positive working relationship with distributors is maintained

  • Review and assist with the resolution of quality related issues

  • Monitor and re-evaluate distributor at defined intervals via Report Card

  • Maintain Approved Distributor List and Distributor file, including change control

  • Prepare distributor metrics; support Management Review process

  • Perform other duties & projects as assigned

  • Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management

  • Work closely with relevant Divisional functions and local cross functional team to support business needs

Your Profile:

  • Bachelor’s degree in Life Science, Engineering, Supply Chain or closely related discipline is required OR relevant combination of education or experience

  • Fluent English verbal and written

  • A minimum of 3 years of experience in Quality, Medical Device or Pharmaceutical industry or related experience is required. Experience in auditing, CAPA, cold chain product management, working with International plants and affiliates is preferred

  • Understands and is able to apply knowledge of international quality systems and medical device standards, such as ISO 13485, ISO 9001, IVDR, etc.

  • Must have the ability to work and interact with many cultures in many time zones and be capable of interpreting and analyzing technical data from different regions for decision making

  • Excellent verbal communication skills appropriate for acting as a liaison between APOC and its distributors/suppliers.  Must be able to make accurate assessments with limited time during an audit.  Must be able to determine important data to obtain and not be afraid to request it.  Must exhibit self-confidence and make on the spot decisions

  • Strong writing skills, including composition and grammar, in order to draft effective audit reports

  • Effective organizational and time management skills

  • Characteristics which enable the individual to succeed are the following: organization, proactive approach, and data driven decision making

  • Must show self-initiative but be comfortable in the role of a team player.  Must be able to work independently with minimal supervision

  • Must be proficient in use of personal computer and business/technical software (e.g., Microsoft Office)

  • Willingness to travel frequently to Africa and Middle East countries

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:

APOC Point of Care

LOCATION:

Germany > Wiesbaden-Delkenheim : G20

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 50 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable

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Commercial Quality Specialist EMEA (m/f/d)

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