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Technical Content Specialist

hace 2 meses

Madrid, Madrid, España Importante Empresa A tiempo completo

**Job Summary**

Importante Empresa is seeking a highly skilled Technical Content Specialist to join our Quality department. As a Technical Content Specialist, you will be responsible for developing and updating process documentation, including assembly procedures, test procedures, routers, travelers, BOMs, process flows, and process FMEAs.

**Key Responsibilities:**

  • Develop and update process documentation to ensure accuracy and compliance with regulatory requirements.
  • Collaborate with the training team to develop short videos that supplement hands-on training.
  • Work with cross-functional teams to develop and edit work instructions and assembly documentation.
  • Support and implement company goals and objectives, policies and procedures, Good Manufacturing Practices, Good Documentation Practices, FDA QSR, and ISO regulations.
  • Regularly report on project status, schedule progress, and key project metrics through scorecard presentations.
  • Assist the engineering team to qualify and optimize processes and tooling via documentation for IQ/OQ/PQ, preventive maintenance, Gage R&R Studies, Process Capability Studies, and Designs of Experiments.
  • Participate in the implementation of internal corrective actions and audit findings.
  • Maintain accurate documentation of concepts, designs, and processes while maintaining current knowledge of medical, technical, and biomedical developments related to company products.

**Requirements:**

  • Bachelor's degree in life sciences and/or writing; medical device experience preferred.
  • 2+ years of technical documentation experience.
  • Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team.
  • Proficient in Microsoft Office Suite.
  • Working knowledge of QMS desired.
  • Willing and able to travel internationally (~5%).

**Preferred Qualifications:**

  • Medical device experience.
  • Knowledge of FDA QSR and ISO regulations.
  • Working knowledge of SAP.