Katalyst Healthcares & Life Sciences
Design Quality Engineer
Katalyst Healthcares & Life Sciences, Marlborough, Massachusetts, United States, 01752
Job Title
Responsibilities: Ensure design verification and validation activities meet regulatory requirements. Support new product development and sustaining engineering projects, ensuring compliance with FDA QSR, ISO 13485, and ISO 14971. Collaborate with R&D, Regulatory, and Quality teams to manage design risk and test method validation. Lead Health Risk Assessments for market products...
Responsibilities: Ensure design verification and validation activities meet regulatory requirements. Support new product development and sustaining engineering projects, ensuring compliance with FDA QSR, ISO 13485, and ISO 14971. Collaborate with R&D, Regulatory, and Quality teams to manage design risk and test method validation. Lead Health Risk Assessments for market products...