Quality Systems Specialist

hace 1 semana


San José, San José, Costa Rica Orbicor A tiempo completo

**Job Description:**

The Quality Systems Specialist will be responsible for ensuring the development and implementation of quality systems that meet regulatory requirements. This role will work closely with cross-functional teams to influence key stakeholders and provide training, leadership, and mentorship to team members.

**Responsibilities:**

  • Develop and maintain quality design documentation and support teams during design reviews.
  • Lead design quality activities for new product development, ensuring all aspects of design controls are robust and compliant.
  • Provide quality input to product user needs, design inputs, and design specifications.
  • Support risk management planning, use/design failure mode effects analysis (FMEA), risk control, and mitigation.

**Requirements:**

  • University degree in an engineering field or equivalent experience in quality area or related field.
  • Minimum 5 years of experience in quality areas support.
  • Experience with medical devices research and development and manufacturing environment.
  • Knowledge of ISO 13485, FDA QSRs, and EU MDR is a plus.
  • Experience managing QA teams and projects.


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