Quality Management Specialist - Katalyst Healthcares & Life Sciences : Job Details

Quality Management Specialist

Katalyst Healthcares & Life Sciences

Job Location : South Plainfield,NJ, USA

Posted on : 2024-12-19T08:32:02Z

Job Description :
Responsibilities:
  • Develop QMS and overall Product Quality Methodology (i.e. product development process, tools/process such as FMEA, dFx, NPI, manufacturing, quality assurance).
  • Develop and implement Quality Documentation Approach, Needs, and Gaps (SOPs, Policies, forms/templates, etc.)
  • ISO 9001 Ready/Capable by roughly end of 2024.
  • Support existing team members with training, reviewing existing processes, documents, capabilities, identify gaps/opportunities, recommend improvement or optimizations, and help develop a robust plan for short to long term QMS needs
Requirements:
  • BS Degree minimum with 10+ years of industry experience.
  • A blend of medical device and pharma experience is okay, but consultant must have strong medical device or diagnostic lab equipment experience.
  • Prior experience conducting QMS implementations.
  • Engineering background.
  • This engagement will be limited to the Engineering side of our client's business and not the pharma side.
  • Strong experience surrounding ISO 9001.
  • Prior auditing experience with ISO 9001 is preferred but not required.
  • Demonstrates strong understanding and ability to develop trainings, processes, and QMS related documentation.
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