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Senior QMS Validation Systems Analyst (2703452)
Location:
Acton, MA
Description:
Perform complex business and systems analysis work; conduct requirements gathering/analysis via information gathering sessions with business users and technical staff. Develop supporting process flows. 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 QA/RA 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 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.**Can work remotely, but the employee must reside within normal commuting distance of the worksite in Acton, MA.** 40 hours/week, 9:00am-5:00pm.Four (4) years of experience in an occupation in which worked/supported Quality, Manufacturing, and Operations teams in pharmaceutical, medical device, or in any regulatory controlled industry. Experience must include: Two (2) years of experience in the following (experience may be gained concurrently):? Working on projects or programs related to Quality/Regulatory? Software and systems development lifecycle.A Bachelor's degree or its equivalent in a Science, Engineering, or Technical discipline. Will accept a bachelor?s degree equivalent based on a combination of education as determined by a professional evaluation service. Please copy and paste your resume in the email body do not send attachments, we cannot open them and email them at candidates at placementservicesusa.com with reference #2703452 in the subject line.Thank you.
Company:
Placement Services USA
Posted:
July 8 on PostJobFree
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More About this Listing: Senior QMS Validation Systems Analyst (2703452)
Senior QMS Validation Systems Analyst (2703452) is a Technology Systems Analyst Job at Placement Services USA located in Acton MA. Find other listings like Senior QMS Validation Systems Analyst (2703452) by searching Oodle for Technology Systems Analyst Jobs.
Senior QMS Validation Systems Analyst (2703452) is a Technology Systems Analyst Job at Placement Services USA located in Acton MA. Find other listings like Senior QMS Validation Systems Analyst (2703452) by searching Oodle for Technology Systems Analyst Jobs.