Quality Assurance Specialist for Computerized System Validation

3 weeks ago


Salt Lake, Utah, United States bioMerieux Inc. Full time

strongJob Summary/strongbrbrbioMerieux Inc. is seeking a highly skilled strongQuality Assurance Specialist/strong to join our team. As a Quality Assurance Specialist for Computerized System Validation, you will be responsible for ensuring the quality and regulatory compliance of our software systems.brbrstrongKey Responsibilities/strongbrbr Participate in the delivery of software projects with regulatory implicationsbr Collaborate with the IS team to provide quality and regulatory support for project executionbr Conduct functional and regulatory risk analysesbr Develop and implement validation strategies for Non-Product Softwarebr Contribute to the Change Control process by challenging and validating impact analysesbr Participate in periodic reviews to ensure the validated status of implemented solutionsbrbrstrongRequirements/strongbrbr Bachelor's degree with +5 years of experience in Computerized System Validation or equivalent work experience in the healthcare industrybr Operational experience in quality processes supported by computerized systems, particularly in the healthcare industrybr Experience in implementing digital and XaaS solutions is an advantagebr Expert in the implementation of GAMP (Good Automated Manufacturing Practices)br Advanced knowledge of regulations and standards applicable to software development (such as 21 CFR Part 820, 21 CFR Part 11, ISO9001, and ISO13485)brbrstrongWhat We Offer/strongbrbr A dynamic and challenging work environmentbr Opportunities for professional growth and developmentbr A competitive salary and benefits packagebrbrstrongHow to Apply/strongbrbrIf you are a motivated and experienced Quality Assurance Specialist looking for a new challenge, please submit your application.



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