Quality Engineer

Job Summary

Quantum Surgical is looking for a Quality Engineer to join a team of creative and energetic engineers who are building the next generation of smart tools for minimally invasive therapies.

The Quality Engineer is supporting the Quality Manager to implement and support the Quality Management System according to the ISO 13485:2016 standards and others required guidelines.

The candidate should have experienced a Quality Management System within the medical device industry and implementing procedures, following action plan.

Position will evolve according to the company growth and future projects.

Key Responsibilities

  • Support site quality system activities to ensure compliance with ISO 13485, FDA, QSR, and 93/42 regulations requirements
  • Develop and maintain all necessary procedures and quality documents
  • Promote quality values and continuous improvement by participating and supporting quality training to the employees
  • In charge of Document Control activities
  • Support non-conformance activities for their resolution
  • Support CAPA activities for their closure
  • Establish, monitor, measure and communicate key quality performance metrics

Experiences and Qualifications

  • MS in Engineering/Science or equivalent
  • 3 years minimum of related experience with a quality management system
  • Demonstrated working knowledge of ISO 13485 ,93/42 directive and other medical device related standards (21 CFR 820)
  • Experience and knowledge in CE regulated environment
  • Excellent document writing and reviewing skills
  • Ability to communicate effectively and build relationships with internal/external stakeholders
  • Excellent organization and communication skills
  • Strong team player

Desired Experience

  • Experience in a similar position in the medical device industry in FDA regulated environment
  • Knowledge of ISO 14971
  • Experience in design documentation review