- 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.
- 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