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Quality Engineer in Kayseri at Stryker Corporation

Date Posted: 11/25/2018

Job Snapshot

Job Description

Job Title – Quality Engineer – (Medical Division/SGS)

The Quality Engineer is responsible for planning and implementation of EU MDR requirements by using and evaluating applications of “ISO 13485:2016 Medical devices — Quality management systems —Requirements for regulatory purposes” standard and also other regulatory requirements and strategies of Stryker by communicating and working with site divisional/operational process owners and commercial team members.

  • Develop action plans for EU MDR required items implementation.
  • Develop close collaboration and communication with site project lead, process owners and commercial team members.
  • Communicate with site project lead to track and ensure timely progress of project.
  • Review and disposition changes with process owners which may impact existing and on-going procedures and processes.
  • Assist cross-functional departments in determining appropriate implementations to support compliance to EU MDR.
  • Review and provide input on project aspects related to implementation plan.
  • Prepare, obtain and maintain documentation for Quality Department.

Qualifications:

  • Minimum graduation from Mechanical, Electronic, Industrial, Biomedical Engineering with Bachelor degree.
  • At least 2 years experience in a international organizational business environment
  • At least 2 years experience in ISO 13485:2016 Quality Management System and Medical Device Industry.
  • No military obligation for male candidate
  • Staying or enable to stay in Kayseri city.

Key Talents / strengths for role:

  • Proficiency in Turkish and English
  • Strong project tracking skills
  • High ethical standards and integrity
  • Excellent interpersonal relationship building skills
  • Process consciousness
  • Good analytical and problem solving skills
  • Action oriented, achiever, result driven
  • Good communication skills
  • Business oriented
  • Preferably EU MDD 93/42 knowledge
  • Good understanding of standards and their applicability in medical device industy

Work From Home: No

Travel Percentage: Up to 25%

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