IT Quality Analyst

A medical technology firm is looking for an experienced IT Quality Analyst. This position will assist the company and the IT organization in achieving and maintaining ongoing compliance.This position is in Mahwah, NJ. Job Description: Assist in the establishment, execution, and maintenance of the IT Compliance program. Oversee and manage IT Controls and Compliance administration (Change Control, Incident Reporting, IT Docs). Oversee and manage the Global program of 21 CFR Part 11 Systems Assessment and Remediation; includes Electronic Signature Management, and coordination / establishment of Divisional Policies and Procedures. Lead and manage strategic projects that contribute to the improved state of systems compliance and systems validation; includes design and development of control processes, documentation, training and maintenance. Assist in development of validation/systems compliance training on systems compliance initiatives; provide continuing compliance education support to the Global IT Organization. Develop, execute and manage computer validation activities in accordance with company policies, standards and regulatory expectations; includes preparation and review of validation and qualification protocols, analysis of data, and preparation and review of validation and qualification summary reports. Prefer professional certification and/or formal training in IT Compliance, FDA Validation, 21 CFR Part 11. Certificate and/or formal training in Project Management is a huge plus.  Qualified candidates please send resumes in Word format to BrianEGriffin@mergisgroup Built on more than 30 years of expertise, The Mergis Group is a specialty recruiting firm committed to helping professionals make the best career choices. We connect specialized professionals to leading opportunities that will foster success in their career.