Quality Management Specialist

2 months ago


South Plainfield, United States Katalyst HealthCares & Life Sciences Full time
Responsibilities: Develop QMS and overall Product Quality Methodology ( 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 Ready/Capable by roughly end of . 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 + 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 . Prior auditing experience with ISO is preferred but not required. Demonstrates strong understanding and ability to develop trainings, processes, and QMS related documentation.

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