This position will work in the Documentation Control Group. Knowledge and experience working with controlled documents, and document control processes is highly preferred.
This position will manage a single large project or several smaller projects. The selected candidate will expedite, manage, implement, and coordinates a multitude of interrelated activities including QA/RA requirements. Supports division Training quality systems and documents practices into internal processes and procedures. Interfaces with internal auditors and outside regulatory agencies/auditors as the subject matter expert for area of expertise. Supports implementation, training and monitoring of projects and programs related to Training and/or Quality Systems to ensure that cGMP requirements are continuously being met. Prepares and presents Training system progress reports to keep management informed. Anticipates, recognizes and communicates quality issues to the appropriate organization and develops actions to resolve the issues. Prepares and presents written and oral reports and other presentations to internal and external audiences.
Bachelor's degree in engineering, scientific or technical area with 3-5 experience in regulations and standards affecting medical devices.
Job details are sourced from the employer's original posting.
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