Quality and Continuous Improvement Manager- Bioprocessing

2 months ago


Fort Worth, United States HK Recruiting Full time
Job DescriptionJob Description

Our client designs, engineers, and manufactures customized production equipment for modularized, single-use processing in the biopharmaceutical industry. Our client's core product offering includes single-use bins, mixers, bioreactors, tube management systems, and other equipment for biopharmaceutical research and production. Our client maintains long-standing customer relationships with biopharmaceutical manufacturers as well as integrators and engineering houses. The Company is based in Fort Worth, TX.

Summary

Given the diverse background and knowledge base required, the anticipated role will be correspondingly dynamic within the engineering/quality organization of the Company. While the exact title can be open for discussion, in practice we anticipate this position leading the ongoing development, implementation, monitoring, and continuous improvement of our client's Quality Management System.

In this role, key job requirements will include but not be limited to:

  • Oversee the design and implementation of all aspects of the company's Quality Management System: Review, approve and support implementation of QA procedures and documents, Optimize QA processes, establish metrics for (QMS), Implement specific ISO 9001 standards as applicable/practical
  • Oversee creation of comprehensive equipment validation documentation (Master Site Validation)
  • Management documentation processes for customer orders (turnover packages, calibration/testing procedures, documentation, manuals, etc.)
  • Manage and optimize Company SOP's
  • Support/ host customer quality audits as required. Address concerns and required actions
  • Manage and lead customer Factory Acceptance Testing



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