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Commercial Quality Specialist MedTech

Auris Health

Auris Health

Quality Assurance
Budapest, Hungary
Posted on Saturday, September 9, 2023
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Description

·        Support Central regional organization to ensure the maintenance of the Quality Systems as per Johnson and Johnson Quality Standards, ISO 9001 Standard and established quality goals

·        Ensure efficient information flow and effective communication of all relevant quality matters

·        Establish corrective action & preventive actions to mitigate potential or actual noncompliance

·        Support Supplier/Distributor Monitoring Program, as applicable;

·        Manage the Training Program, as applicable;

·        Manage the Field Actions and Product Complaints Management Program, as applicable;

·        Record and manage quality issues, escalating serious events to senior management;

·        Support hosting and managing of internal and external audits and inspections;

·        Support creating inputs for management review process and quality planning;

·        Participate in local and regional quality/compliance projects.

Qualifications

  •        Bachelor’s degree in bioscience, engineering, or business.
  •        Working experience in the Medical Device Industry in quality/regulatory function.
  •        Strong collaboration skills and ability to build partnerships internally and externally.
  •        Excellent written and oral English communication skills.
  •        Advanced computer skills in MS Office.