Location
Danvers, MA, United States
Posted
July 04, 2026
Job Description
Job Description
Our client is seeking an MQSA Engineer to join the Quality Systems team. This role ensures compliance with microbiological quality and sterility assurance standards across manufacturing and product development processes. The ideal candidate will have expertise in sterility assurance, microbiology, and regulatory compliance within a medical device environment.
Key Responsibilities
-Develop, implement, and maintain sterility assurance programs for medical devices in compliance with FDA QSR, ISO 13485, and ISO 11135/11137 standards.
-Provide technical leadership for cleanroom validation, bioburden testing, and environmental monitoring programs.
-Support sterilization process development and validation (e.g., ethylene oxide, gamma, steam, or gaseous sterilization methods).
-Conduct risk assessments related to microbiological contamination and sterility assurance.
-Collaborate with R&D, Manufacturing, and Quality teams to ensure sterility requireme...
Our client is seeking an MQSA Engineer to join the Quality Systems team. This role ensures compliance with microbiological quality and sterility assurance standards across manufacturing and product development processes. The ideal candidate will have expertise in sterility assurance, microbiology, and regulatory compliance within a medical device environment.
Key Responsibilities
-Develop, implement, and maintain sterility assurance programs for medical devices in compliance with FDA QSR, ISO 13485, and ISO 11135/11137 standards.
-Provide technical leadership for cleanroom validation, bioburden testing, and environmental monitoring programs.
-Support sterilization process development and validation (e.g., ethylene oxide, gamma, steam, or gaseous sterilization methods).
-Conduct risk assessments related to microbiological contamination and sterility assurance.
-Collaborate with R&D, Manufacturing, and Quality teams to ensure sterility requireme...