Quality Assurance Team Leader Meditera Tıbbi Malzeme Sanayi ve Ticaret A. Ş. İzmir

  • izmir

QUALIFICATIONS AND JOB DESCRIPTION

Qualifications

  • Graduated from relevant engineering departments of universities,
  • Minimum 6 years of relevant work experience in quality control and quality assurance area
  • Preferably experienced in medical device field,
  • Strong knowledge of ISO 13485:2016, MDD 93/42/EEC and MDR 2017/745/EU requirements,
  • Preferably knowledgeable and experienced in FDA processes,
  • Experience in Problem Solving, Team and Project Management
  • Excellent organizational and leadership skills
  • Experience in management of employees
  • Excellent command of written and spoken English,
  • Excellent communication skills, both written and verbal,
  • Self motivated, result and quality oriented, systematic personality,
  • Knowledge about ERP Systems and QDMS is prefered.
  • Having the ability to use time effectively by distributing the workload effectively,
  • Able to review, trend, analyze and report data using databases and/or Excel,
  • In depth understanding of quality control procedures and relevant legal standards
  • Male candidates must have completed their military service,
  • Preferably residing or able to live in Tire.

Job Descrıptıon

  • Responsible from the application and maintenance of Quality Management System,
  • Support and all departments in performing their quality assurance duties and train them when necessary,
  • Follows up all related national and international standards, and in case of changes; plans changes with the manager. Drives annual internal audit and follows up corrective and preventive actions,
  • Managing contractors and subcontractor complaints processes,
  • Leading the document control process,
  • Managing customer complaints,
  • Leading the calibration processes,
  • Audits Quality Control processes in all production areas including input and final quality control,
  • Manage and provide full performance of the quality assurance and control teams in any duty assigned to them by any processes of the company,
  • Prepares monthly quality reports and presents monthly Production and Quality evaluation presentations.

PREFERRED CANDIDATE

Years of Experience:

More than 6 years of experience

Military Status:

Completed

Level of education:

Bachelor’s(Graduate), Master’s(Graduate)

Languages:

English( Reading : Advanced, Writing : Advanced, Speaking : Advanced)

POSITION INFORMATION

Company Industry:

Medical products

Job Role:

Quality

Job Type :

Permanent / Full-time

Number of vacancies:

Not Specified

Job Location:

İzmir

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