QMS Consultant

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:

• 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