FITS, LLC
We are seeking a candidate for validation services in the Manufacturing area.
What Makes You a Fit:
The Technical Part:
Bachelor’s Degree in Engineering and three (3) years of experience within the Medical Devices Industry
Bilingual: Spanish and English
Soft Skills: Writing and communication skills
Shift: 1st and according to business needs.
Experience in:
Process and Computerized Systems Validation
The evaluation, qualification, and documentation of computerized systems and manufacturing processes.
Configuring and Troubleshooting Windows.
The Personality Part:
We are looking for someone who treats everyone they meet like family, especially our resources, clients, and team members. Being a customer service pro is one of your talents. You should be full of bright ideas and eager to innovate, always bringing top-quality results to the table.
As a Piece of FITS, You Will:
Evaluate the impact of validated computerized systems on existing work instructions and processes
Prepare and execute computer system validation protocols and generate a comprehensive report
Develop and maintain Installation Qualification (IQ) documentation
Collaborate with process owners to implement changes to work instructions and ensure compliance
Inspect machinery, equipment, and tools to verify performance and initiate corrective actions as needed
Ensure adherence to company procedures, quality system regulations, and industry standards
Apply technical expertise and knowledge of Medtronic’s engineering practices to optimize equipment and manufacturing techniques
Organize and track project progress, maintaining detailed documentation and status updates
Contribute to cross-functional projects and support milestone completion
Communicate effectively with internal stakeholders to share updates, gather input, and support decision-making
Who We Are:
We are a Service Provider company that integrates Engineering, Construction, Maintenance, Utilities, and Specialized Technical services. We pride ourselves on how we treat our employees and provide top-notch quality talent to our Pharmaceutical, Medical Device, and Manufacturing industry clients.
Equal Employment Opportunity (EEO) Statement:
FITS, LLC is an equal opportunity employer and welcomes applications from diverse candidates.
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