Quality Manager

2 days ago


Konak, Turkey Maxwill International Full time

We are looking for a Quality Manager for our global client operating in the manufacturing sector that we are consulting.

Responsibilities
  1. To ensure that the Quality Management System is established, implemented and developed in line with the objectives of the company.
  2. To check the operability of the implemented Quality Management System at every point of the company.
  3. To prepare / have prepared procedures and instructions related to quality, to have them approved and to ensure that they are used.
  4. To follow the measurement and inspection equipment used to show that the product produced complies with the specified conditions within the scope of the procedure applied.
  5. To make and report periodic statistical analyses of quality control data in all processes.
  6. To ensure the distribution and updating of the documents constituting the quality system and to implement the necessary procedures to prevent the re-use of the abolished documents and to ensure their follow-up.
  7. To initiate/ensure the initiation of necessary corrective/preventive actions in co-operation with other departments when the required quality standards are not met.
  8. To keep records of quality control devices subject to calibration and to follow calibration periods.
  9. To participate in supplier evaluation studies carried out in certain periods.
  10. To follow up and develop relations with external organisations on issues related to the Quality System.
  11. To prepare the annual audit plan, train the members of the internal audit team, fulfil the necessary duties as the Chief Internal Auditor and ensure continuous communication/reporting of the results.
  12. To ensure that all employees comply with all occupational health and safety and environmental rules in the Occupational Health and Safety Instruction and Undertaking, which are notified to them at the beginning of their employment, during working hours and to take the necessary measures.
  13. In the event that the products supplied to the market do not comply with the MDD and MDR; immediately take the necessary corrective action to bring this device into compliance or recall it.
  14. To be responsible for leading the implementation in case of decisions to issue adverse event notifications or withdrawal from the market after evaluation and to submit to management approval for final decision.
Qualifications
  • Graduated from the relevant departments of universities,
  • Minimum 12 years of experience
  • Experience in team management
  • Advanced knowledge of English (written, spoken)
  • Able to use Ms Office and Logo programmes at a good level
  • Mastery of MDR, MDD processes,
  • Knowledge of FDA regulations
  • Master ISO 13485 certification processes
  • Knowledgeable and experienced in quality management systems and product certification,
  • Developed analytical thinking and problem solving skills,
  • Strong planning, research, organisation and follow-up skills,
  • Solution orientated and strategic thinker,
  • Open to teamwork, development and innovation,
  • Effective, planned and disciplined in time management.
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