Quality Assurance Specialist FGO QMS

2 tygodni temu


Warszawa, Mazovia, Polska Stryker Group Pełny etat

Stryker Group is seeking a Quality Assurance Specialist FGO QMS to support the oversight and assessment of changes to our quality management system. As a key member of our team, you will ensure that all changes are compliant, effective, and do not pose any risk to our products or processes.

Responsibilities:

  1. Participate in Change Control review forums and multi-site forums to execute and review changes for sound rationale, challenging justification, correct approval, and oversight.
  2. Facilitate and mentor teams through all stages of the change control process, reviewing changes for compliance with relevant corporate procedures.
  3. Act as Product Manager within our Quality Management System, setting up new projects, moving and assessing objects within containers, establishing groups within containers, and troubleshooting issues in onePLM.
  4. Interface and troubleshoot issues between the onePLM system and various departments/project teams, ensuring solutions are implemented in a compliant, timely, and fully traceable manner while meeting business timelines and milestones.
  5. Serve as Subject Matter Expert on related procedures and processes, ensuring compliance with relevant corporate procedures.
  6. Support training needs related to the change control process and manage Change Control KPIs including reporting requirements.
  7. Coordinate preparation, participation, and follow-up for Stryker Internal, Corporate, and third-party compliance audits.

Requirements:

  1. Bachelor's degree in a Science, Engineering, or related discipline preferred.
  2. 2 years in Quality/Regulatory Affairs environment with 1 year experience in a role exposed to Quality Management Systems.
  3. Fluency in English essential.

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