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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.