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Quality Systems SME (Rewrite)

Company Name:
ALKU
Environment:
Our client is a global leader in diagnostic and reagent healthcare products. They research, develop and manufacture a number of medical devices and biologics. They are in need of a Quality Systems SME to rewrite the Quality System documentation so that it reflects the specific activities that take place in this particular business unit. Once completed, the SME will support the harmonization of this QS with a different business unit's more comprehensive QS.

Principle Duties and Responsibilities:
The consultant will extensive experience in ISO 13485 environments, specifically writing Quality Systems. Currently, this business has a Quality System that doesn't accurately reflect the activity taking place on-site. This business unit is strictly R&D, but the Quality System reflects one that includes both Design and Manufacturing. As such, the Quality System must be rewritten and streamlined so its content reflects their R&D activity such as Design Controls, Design Verification & Validation, and Design Transfer. There is very little process writing or changes to the processes already in place within the QS. The individual will be much more focused on removing the old manufacturing content, and rewriting the Design Quality content to reflect the site's R&D work. This initial rewrite MUST be completed within a month, in order to maintain their certification. This is highly time-sensitive work and will be intensive.
Once this basic content is rewritten and the site's local certification is reapproved, this individual will focus on coalescing the local Quality System with a different business unit's Quality System in California. This will involve more process change, and more detail oriented QS cleanup work (as the initial month will likely result in a fairly bare-bones Quality System). These process changes and cleanup will ultimately aim to reflect the comprehensive QS already in place the California business unit.

Required:
Medical Device & Pharma: 8-10 yrs
Quality Systems Writing: 8-10 years
ISO 13485, 21 CFR Part 820, ISO 14971
Gap Analysis



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