Senior Quality Engineer

Cleveland, OH     ·       Full time

Location: 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+ years of Quality Engineer experience in medical device industry.
• Strong self-starter, effective team player, and detail-oriented required.
• Understanding of US 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.

Please click here to learn more.