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Quality Engineer

Cleveland, OH

Responsibilities:

  • Ensures product development activities are conducted in accordance with FDA, QSR, ISO 13485 and internal Quality System requirements.
  • Support cross-functional development project teams to ensure that new products and product changes are adequately evaluated/tested with respect to requirements and product Design History File is complete.
  • Develop and maintain risk management files through active participation in risk management activities from product conception through commercialization.
  • Supports the needs of contract manufacturers and product release activities.
  • Contribute to sustaining the quality management system and the software on which it is run, including validating routine software updates.
  • Support and/or lead internal and external audits, product complaint processing, CAPAs, and nonconformances.

Requirements:

  • Bachelor’s degree in Engineering.
  • 5-7 years of Quality Engineer experience in medical device industry.
  • Strong self-starter, effective team player, and detail-oriented required.
  • Understanding of US, Eu and ROW medical device regulatory compliance requirements (ISO 13485 and FDA’s QSR).
  • An effective oral and written communicator with the ability to lead meetings and clearly present ideas to employees and other stakeholders.
  • Ability to work efficiently and creatively in a regulated industry.

Why Join Our Team?

  • Entrepreneurial work environment – A growth oriented and collaborative atmosphere in the medical device industry!
  • Ability to work with game changing technology.
  • Competitive compensation and benefits
  • Employee Wellness Program
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