What are the responsibilities and job description for the Quality Specialist position at Intelliguard?
To be considered please apply here: https://app.hiremojo.com/mojo/ce/499468690/IntelliGuard/California/San-Diego/Quality-Specialist
Quality Specialist I
San Diego, California - Full Time
PURPOSE
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
- Complaint Handling will be the main function of this role; however, this role is intended to develop and grow into other areas of the Quality Management System.
- Expert understanding of FDA regulations concerning complaint handling, and Medical Device Reporting (MDRs) per 21 CFR Part 803.
- Knowledgeable of ISO 13485:2016 and 21 CFR Part 820 requirements.
- Ensure complaint investigations are adequate, accurate, detailed, and processed within a timely manner. Ensure investigations are assigned, track investigation progress and ensure root cause determination.
- Evaluate adverse events, product quality complaints, and conducts complaint investigation in accordance with IntelliGuard’s Standard Operating Procedures (SOPs).
- Perform complaint case review, conduct trend analysis, perform investigation and escalation, as appropriate.
- Develop and deliver training presentations for complaint process and systems.
- Prepare and present Complaint data to Management.
- Lead various projects and activities related to Complaint process and system implementations and improvements.
- Participate in and share complaint information with various cross-functional teams.
- Monitor Complaint Records in system to ensure standard process is being followed and complaints are closed as required.
- Complaint documentation meets Good Documentation Practices (GDP).
- Participate in CAPAs related to Complaints.
QUALIFICATIONS
- Bachelor’s degree in Science or Engineering or equivalent work experience.
- Experience (2 – 3 years) working in complaint handling and MDR processing per ISO 13485:2016 and FDA regulation requirements.
- 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.
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*
The expected salary range for this position based on the primary location of California is $65,000 – $75,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.
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.
To be considered please apply here: https://app.hiremojo.com/mojo/ce/499468690/IntelliGuard/California/San-Diego/Quality-Specialist
Job Type: Full-time
Pay: $65,000.00 - $75,000.00 per year
Experience level:
- 2 years
Schedule:
- Monday to Friday
Work setting:
- In-person
- Office
People with a criminal record are encouraged to apply
Work Location: In person
Salary : $65,000 - $75,000
