About IntelliGuard Group, LLC

At Intelliguard, we believe patients deserve better—and we’re here to make that happen.

We’re a purpose-built healthcare technology company on a mission to help hospitals and health systems focus on what matters most: the patient. By transforming fragmented medication data into real-time intelligence, we empower clinicians, pharmacists, and care teams to make smarter, safer decisions.

Our AI-powered Mira Ecosystem™ unifies RFID automation, real-time visibility, and predictive analytics into a single, integrated platform. Unlike legacy systems that rely on manual processes and deliver only partial data, Intelliguard provides unmatched accuracy and insight—delivering the clarity and control required for patient-centered operations.

Trusted by over 600 hospitals, pharmacies, and surgery centers across North America, we’re pioneering a new standard in medication intelligence—and we’re just getting started.

If you’re passionate about using technology to drive impact and shape the future of healthcare, we’d love to meet you. Join us and be part of a team building something that truly matters.

Learn more at intelliguardhealth.com

About the role

Intelliguard has an excellent opportunity for a Quality Engineer to join our team in Columbus, OH reporting to the Quality Manager. As a Quality Engineer you will be responsible for assisting in developing, coordinating, facilitating, and implementing quality assurance standards based on applicable FDA and ISO requirements across all applicable products and processes.

What you’ll be doing:

·       Participate in the development, implementation, management, and integration of a Quality Management System (QMS) per ISO 9001 . 

·       The incumbent in this position directly reports to the Quality Manager and holds a key role in assisting management with the development and implementation of internal controls, standards, processes, and procedures for managing the company’s QMS and quality programs.

·       The incumbent implements quality assurance methods, participates with internal Quality training for all employees, monitors conformance with QA standards and procedures and participates in creating methods for overall process improvement for products and processes.

·       Participate in the initiation, documentation, and processing of quality events (e.g. deviations, CAPA, change control, complaints, product returns/recalls).

·       Conduct employee training on applicable Quality SOPs, work instructions and regulatory requirements under the guidance of Quality Management

·       Serve as a quality contact and resource for quality events or nonconformance identifications, report write-ups and quality event documentation/investigations.

·       Perform root-cause analysis and other problem-solving activities utilizing appropriate failure investigation tools (e.g. 5 “Whys”, Fishbone, 6M’s etc.) to identify effective corrective and preventative actions, measures and process improvements

·       Proposes appropriate correction, corrective and/or preventive action plans and measures verification effectiveness of CAPAs. Ensure CAPAs are processed to closure. 

·       Participate in the design, implementation, and documentation of procedures for process control, process improvement, testing and inspection.

·       Maintain/generate quality metrics (process capability, control charts, measurement quality) for monitoring system effectiveness and to enable managers to make sound product quality decisions.

·       Report to management all quality issues, trends and/or losses

·       Maintain collection and analysis systems of statistical data to predict trends that will affect improvement of product quality.

·       Establish, and ensure supplier quality requirements are met and implement supplier quality corrective actions as appropriate per procedure.

·       Perform internal and participate in external customer or notified body quality audits.

·       Conduct supplier assessments and routine/qualification audits in accordance to Supplier Management program.

·       Prepare audit plans, agenda and final reports based on audit findings as appropriate. 

·       Interface with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action plan is implemented.

·       Other duties as assigned or identified by Quality Management. 

We would love to hear from you, if:

·       Bachelor’s degree in science or equivalent work experience. 

·       Experience (2-3 years) working in an ISO or FDA regulated environment. 

·       Experience (2-3 years) in a Quality Assurance related role. 

·       Must have excellent skills in organization, negotiation, problem solving and time-management. 

·       Able to attend to detail and act decisively. 

·       Ability to work under pressure, manage several tasks at once and meet tight deadlines. 

·       Must have excellent interpersonal, written, oral presentation and verbal communication skills. 

·       Proficient in Microsoft Word, PowerPoint, Excel, and SharePoint. 

·       Must be able to travel domestically/internationally (~15%). 

Why you should join us:  

·       Generous Paid Time Off (Vacation, Sick, 10 Holidays, Floating Holiday Time)

·       Medical, Dental, Vision Plans

·       401K with Employer Match

·       Life/AD&D and Long-Term Disability (LTD)

·       Flexible Spending Account (FSA)

·       Voluntary Life/AD&D Optional Plans

·       Pet Plan

·       To play a part in helping hospitals and health systems continuously improve the environment of safety around every medication decision!

OTHER INFORMATION:

The essential functions of the job are usually performed in an office setting, where the noise level in the work environment is usually low to moderate. 

While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 35 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and the ability to adjust focus.

*Relocation assistance is NOT available for this role.

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