Roles & 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 .
Education & Experience :
- 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.
- 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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