- 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
- 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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The Plus Group Hayward, United StatesJob Description · Job DescriptionDirect Hire opportunity to become a Support Buyer with a well-established company in the Hayward Ca area. The Supply Chain group in seeking someone who will be responsible for identifying and procuring materials, equipment, and all externally prov ...
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Principal Quality Control Specialist
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Arsenal Biosciences Hayward, United StatesWHO WE AREArsenal Biosciences Inc. is a clinical stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors. We are seeking a talented and experienced Senior Manager, Quality Control to work onsite based in our Hayward office. ArsenalBio's ...
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Penumbra Alameda, United StatesThe Technical Training Leader ensures that Penumbra continues to provide technical and professional employees at all levels with the skills they need to grow with the company. · Guides the training team in the development, facilitation, and management of technical and profession ...
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QMS Consultant - Hayward, United States - Redbock - an NES Fircroft company
Description
QMS CONSULTANT
Part time- Full time (20-40/hours a week fluctuating)
REMOTE - (supporting PST)
Overview:
A leading biotechnology company is seeking to prototype and potentially industrialize, and commercialize, a high-resolution microscopy that incorporates various other automation and data capture elements and can be suitable for in-lab benchtop use. This person will be responsible for developing QMS capabilities in-line with this design, development, and prototyping process.
Responsibilities:
Requirements:
