QMS Validation Systems Analyst

December 3

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Diabetes Youth Families

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11 - 50 employees

Founded 1938

⚕️ Healthcare Insurance

🔧 Hardware

Description

• Perform complex business and systems analysis work; conduct requirements gathering/analysis via information gathering sessions with business users and technical staff. • Conduct analysis of existing business processes; recommend process improvements. • Understand Business and Functional Requirements, use cases, scenarios, process flows, system interface diagrams, test protocols and test reports. • Work with Business stakeholders in the QARA organization, IT, and vendors to deliver and maintain validated solutions that comply with Insulet SOPs, Procedures, and the Code of Federal Regulations (CFR) as it relates to medical devices. • Represent business interests in working with vendors to design a solution that accurately represents the business requirements. • Support all aspects of building new capabilities, enhancing, and supporting QMS and related systems in collaboration with Insulet Business Teams, IT leadership and Project Management. • Assist with the development of training materials and support ‘train the trainer’ sessions with business SME’s to improve adoption and efficient use of all systems related to the QMS. • Create and manage complex workflows in the QMS as they pertain to business process. • Create functional design documentation based on business requirements. • Communicate effectively with business users on the status of enhancements, projects and open production support tickets. • Coordinate test activities. • Initiate and lead information gathering discovery meetings with stakeholders at all levels, both internal and external to the organization. • Performs other duties as assigned.

Requirements

• Bachelor’s Degree and/or equivalent combination of education and experience. • At least 3 years of experience working with Quality Management System(s). • At least 2 years of experience working in a Business Analyst role. • At least 2 years of experience working on projects or programs related to Quality/Regulatory groups. • Training in QMS system administration and/or development preferred. • Proven knowledge of the software and systems development life cycle. • Strong experience and knowledge of requirements gathering tools and techniques. • Medical Device experience is a plus. • Working knowledge of CAPA, NCMR, Deviations, , GxP, 21 CFR Part 820 is required. • Strong experience and knowledge of the Seimens Polarion ALM (Application Lifecycle Management) Tool. • Experience with Service Now or traditional support ticket and change management system is a plus. • Proven ability to provide business analysis and system configuration deliverables related to process improvement. • Experience with Agile and traditional methods of project management, requirements gathering and analysis is desired. • Experience supporting or working with an IT QMS organization, preferably in the pharmaceutical, medical device, or other regulatory controlled industry.