QUALIFICATIONS AND JOB DESCRIPTION
In connection with the expansion of our Global activities; we are looking fordynamic, friendly, hard working,enthusiastic, resilient, talentedand most importantly an idealistic candidates for “Quality Assurance and Regulatory Specialist” role.
SUCCESSFUL APPLICANT QUALIFICATIONS
· Minimum Bachelor degree,
· Experience in Quality&Regulatory processes will be an asset.
· Has strong knowledge about ISO 9001 and will be an asset knowledge for ISO13485,
· Excellent spoken and written English,
· Advanced computer skills, expert in Microsoft Office programs,
· Ability to overview and solve complex business processes and techniques,
· Ability to multitask efficiently,
· Have problem solving and analytical thinking skills,
· Adopted careful and regular work,
· Capable of working effectively in stressful and difficult conditions,
· Prone to teamwork,
· No travelling restrictions,
· No military obligation for male candidates.
OVERALL JOB DESCRIPTION
· Responsible for the whole Quality Assurance System to full compliance,
· Responsible for CE Product Technical Files and Product Certifications accordingly,
· Preparations of documents for registering products in the countries including Turkey,
· Ensure the local regulations are met,
· Ensure product traceability activities,
· Following local&international regulations’ changes and take proper actions proactively,
· Applying efficiently post market surveillance activities,
· Carrying out relations with Notified Bodies, Competence Authorities, Regulatory parties and all third parties in a way of professionaly representing the company.
· Carrying out the audits/inspections by Notified Bodies, Local Authorities, Customers and any Regulatory Third Parties efficiently.
· Handling Customer Satissfaction to full compliance.
· Will be able to make suggestions and contributions to improve the work done,
· Other responsibilities of declared by management as not limited with above points.