Quality Assurance and Regulation Specialist İş İlanı
İşveren Hakkında
QUALIFICATIONS AND JOB DESCRIPTION
In connection with the expansion of our Global activities; we are looking for dynamic, friendly, hard working, enthusiastic, resilient, talented and most importantly an idealistic candidates for “Quality Assurance Specialist” role.
SUCCESSFUL APPLICANT QUALIFICATIONS
. Communication with auditor companies
. To prepare and coordinate the product file requested by the Health authorities in foreign markets.
. Responsible for the preparation of the technical file
· Minimum Bachelor degree, preferably in the field of Biomedical Engineer, Bioengineer, Biologist,
· Experience in Quality&Regulatory processes will be an asset,
· Has strong knowledge about ISO 9001 and ISO13485,
Excellent written and verbal communication skills in English,
· Expert in Microsoft Office and Netsis programs,
. Experienced in the medical device industry,
· Ability to overview and solve complex business processes and techniques,
Strong Analytical and problem-solving skills,
· Ability to multitask efficiently,
· Can be adopted long working hours when needed,
· Capable of working effectively in stressful and difficult conditions,
· Ability to work within the team environment,
· Has no travelling restrictions,
· Has no military obligation for male candidates.
OVERALL JOB DESCRIPTION
. Responsible for GMP practices and full compliance of the Quality Assurance Systems throughout the company,
. Carrying out Internal Audits within the company,
. Offering corrective action suggestions for both departments of company and suppliers,
. Creating periodical reports related with her/his department,
. Auditing suppliers periodically,
. Taking part in the Supplier Qualifications and Evaluation,
· Responsible for the CE Product Technical Files and Product Certifications accordingly,
· Arranging of documents for registering products in the related countries including Turkey,
· Ensuring the local regulations are met,
· Ensuring of the product traceability activities,
· Following the revisons of local&international regulations’ and take proper actions proactively,
· Applying efficiently post market surveillance activities,
· Carrying out relations with the Notified Bodies, Competence Authorities, Regulatory parties and all third parties in a way of representing the company professionally,
· Carrying out the audits/inspections by Notified Bodies, Local Authorities, Customers and any Regulatory Third Parties efficiently,
Capable of turning customer feedbacks into action,
· Will be able to make suggestions and contributions to improve the quality of the finished products.
