Katalyst HealthCares & Life Sciences | Newton, United States | Posted June 19, 2026
Job Description
Roles & Responsibilities:
Act as a Quality subject matter expert supporting the development of sterile, single-use medical devices, with ownership of packaging, sterile barrier systems, sterilization, and biocompatibility considerations to ensure compliance with applicable standards and internal quality system requirements. Support risk management activities in accordance with ISO , including identification, analysis, mitigation, and documentation of risks throughout the design lifecycle within the Risk Management File. Support the development of Use, Design, and Process FMEAs to systematically identify and address potential failure modes and ensure appropriate risk controls are implemented. Support design verification and validation activities, including development, review, and approval of test plans, protocols, and reports, with a focus on compliance testing for biocompatible, sterile, single-use consumable products (, ISO , IEC -, packa...