Quality Systems Specialist Jobs

IntelliGuard is a dba of MEPS Real-Time, Inc. IntelliGuard is a technology company using RFID, cloud-based software and data analytics to track and trace critical items in a complex supply chain environment. Today we track and trace medications, controlled substances and other high value items throughout our customers enterprise.
By joining IntelliGuard's Quality team, you will further our mission to improve labor productivity and inventory accuracy within the pharmaceutical industry.
Duties and Responsibilities

• Participate in the initiation, documentation, and management of quality events (e.g. deviations, CAPA, change control, complaints, product returns/recalls).
• Report to management all quality issues, trends and/or losses
• Serve as a quality contact and resource for quality event or nonconformance identification, report write-up and quality event documentation/investigation.
• Participate in the development, implementation, management, and integration of a Quality Management System (QMS) per ISO 13485:2016 and CFR 21 Part 820 requirements.
• The incumbent directs 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.
• Interface with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action plan is implemented.
• Maintain ASL as required.
• He/she is responsible for managing, coordinating, facilitating, and implementing quality assurance standards based on applicable FDA and ISO requirements across all applicable products and processes.
• Participate in the design, implementation, and documentation of procedures for process control, process improvement, testing and inspection.
• Other duties as assigned or identified by Quality Management.
• Conduct supplier assessments and routine/qualification audits in accordance to Supplier Management program.
• Review customer purchase orders, contracts and change requests and ensure that the necessary criteria and provisions are included in quality and process plans.
• Conduct employee training on applicable Quality SOPs and regulatory requirements under the guidance of Quality Management
• 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
• Maintain collection and analysis systems of statistical data to predict trends that will affect improvement of product quality.
• Review suppliers purchase orders, establish, and ensure supplier quality requirements are met and implement supplier quality corrective actions as appropriate per procedure.
• Proposes appropriate correction, corrective and/or preventive action plans and measures verification of effectiveness of CAPAs. Ensure CAPAs are processed to closure.
• 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.
• Prepare audit plans, agenda and final reports based on audit findings as appropriate.
• Perform internal and participate in external customer or notified body quality audits.
• Conduct quality review of documentation including test protocols, summary test reports, IQ/OQ/PQ reports and data for process, test method, equipment, facilities, software or other system validation and qualification activities, as needed.
• Maintain/generate quality metrics (process capability, control charts, measurement quality) for monitoring system effectiveness and to enable managers to make sound product quality decisions.

Qualifications

• Experience (2-3 years) in a Quality Assurance related role.
• Proficient in Microsoft Word, PowerPoint, Excel, and SharePoint.
• Experience (2-3 years) working in an ISO or FDA regulated environment.
• Must have excellent skills in organization, negotiation, problem solving and time-management.
• Must have excellent interpersonal, written, oral presentation and verbal communication skills.
• Bachelor's degree in Science or equivalent work experience.
• Ability to work under pressure, manage several tasks at once and meet tight deadlines.
• Must be able to travel domestically/internationally (~10%).
• Able to attend to detail and act decisively.

Working conditions
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.
Founded in 2006 and headquartered in Carlsbad, CA, IntelliGuard is a leader in critical inventory management solutions for the pharmaceutical supply chain. Our enterprise platform of RFID-enabled solutions empowers hospitals, health systems, research faclities, distributors and manufacturers to automate with confidence and gain intelligent data they can trust. IntelliGuard Intelligent Inventory Solutions improve patient safety, maximize efficiency and reduce costs.