MQSA Engineer - Sterility & Validation

Company Industry : Medical Device Manufacturing Title : Manufacturing Quality and Sterility Assurance Engineer Location : Danvers, MA (4 Days onsite/week) Pay Range : 55–65/hr About the Role A leading medical device organization is seeking a Manufacturing Quality & Sterility Assurance Engineer to join their Quality Systems team. This individual will play a critical role in ensuring microbiological quality and sterility assurance across manufacturing and product development processes. This is an excellent opportunity for someone with strong experience in sterility assurance, microbiology, and regulatory compliance within a regulated environment. Key Responsibilities Develop, implement, and maintain sterility assurance programs 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, gaseous sterilization methods) Conduct risk assessments related to microbiological contamination and sterility assurance Partner with R&D, Manufacturing, and Quality teams to ensure sterility requirements are integrated into design and production processes Author and maintain SOPs, protocols, and reports related to sterility assurance activities Lead investigations for sterility-related nonconformances and drive CAPA activities Support internal and external audits, including regulatory inspections Provide training and guidance on microbiological quality and sterility assurance best practices Qualifications Bachelor’s degree in Microbiology, Biomedical Engineering, Life Sciences, or a related field (Master’s preferred) 3+ years of experience in sterility assurance or microbiological quality within medical device, pharmaceutical, or biotech industries Strong knowledge of sterilization standards and validation requirements Familiarity with ISO 11135, ISO 11137, and related standards Experience with cleanroom operations and contamination control Strong analytical, problem-solving, and documentation skills #J-18808-Ljbffr Insight Global