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Form of workDescription:
This role is responsible for execution of the CAPA processes by owning the event occurrence, investigation, and documentation for any suspected policy, process, or procedure or production related system nonconformity. Responsibilities include:
•Coordinates, reviews, tracks, and reports on the nonconformance, CAPAs, and deviations that are generated as part of the CAPA quality system.
•Prepares and approves documentation per policy and procedure to support the CAPA quality system.
•Assists with analysis of quality data to identify problems or unfavorable trends that may require corrective or preventive actions.
•Provides guidance on the CAPA system, event descriptions, investigations, root cause analysis, and resolution plans.
Top Skills Details:
CAPA,IT Systems Experience, Health Care, Life sciences
Additional Skills & Qualifications:
Candidates should posses good organization, project management and documentation skills. The IT Quality Engineer will work with Systems SME's to compile information, create records and documentation to be reviewed by Auditors. Must have good critical thinking skills and able to synthesize information into a consumable story for an outside auditor to understand. Prior experience with ISO 13458, IEC 62304 would be a plus.
About TEKsystems:We're partners in transformation. We help clients activate ideas and solutions to take advantage of a new world of opportunity. We are a team of 80,000 strong, working with over 6,000 clients, including 80% of the Fortune 500, across North America, Europe and Asia. As an industry leader in Full-Stack Technology Services, Talent Services, and real-world application, we work with progressive leaders to drive change. That's the power of true partnership. TEKsystems is an Allegis Group company.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
