Job Description
Job Description:
Pay Range: $65hr - $70hr
The Design Quality Engineer will serve as a Quality subject matter expert supporting the development of sterile, single-use medical devices. This role has ownership of packaging, sterile barrier systems, sterilization, and biocompatibility considerations to ensure compliance with applicable standards and internal quality system requirements. The position supports both new product development and sustaining quality activities, ensuring products meet regulatory and quality expectations throughout the lifecycle. Responsibilities: Act as a Quality subject matter expert for sterile, single-use medical devices, including packaging, sterile barrier systems, sterilization, and biocompatibility. Support risk management activities in accordance with ISO 14971, including risk identification, analysis, mitigation, and documentation within the Risk Management File. ...