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Quality Inspector

1 month ago

Waukegan, United States HealthSmart Full time
CompanyHealthSmart Job DescriptionOVERVIEW/GENERAL PURPOSE OF THE POSITION

Performs the in-coming verification of various medical devices and consumer products associated within the scope of products offered by DMS Holdings, dba HealthSmart Int’l.; processes complaints and inquiries; interfaces with internal and external customers, manufacturing sites, technical support, commercial organizations and suppliers regarding HealthSmart’s product complaints. Responsible for product complaint documentation entered into the QT9 QMS, investigations and identification of potential adverse events and potentially reportable events.

ESSENTIAL DUTIES AND RESPONSIBILITIES
  • Responsible for the verification of in-coming product
  • Maintains records associated with duties and responsibilities
  • Confirms shipment details against packing lists, P.O.’s, and ERP system
  • Performs investigation on suspect product
  • Performs review of historical records\products as it relates to inspection or investigations
  • Operates within the guidelines of established company procedures and FDA\ISO regulations
  • Prepares documents for, and performs, rework activities
  • Documents product complaints, investigations, and reviews of all non-medical complaint content. Responsible for reviewing medical complaints that involve a non-medical quality related problem. Provide quality customer service
  • Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GCP. This requires good analytical, technical writing and good documentation skills. Responsible that complaint files meet all regulatory requirements.
  • Identifies potentially reportable events and notification to appropriate functional groups and management.
  • Other duties that may be assigned as required.

 

EDUCATION AND EXPERIENCE                  Complete and/or select
  • Bachelor’s Degree preferred or 1-2 years of relevant work experience
  • Minimum of 6 months of related experience in a role responsible for inspection.

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About UsAbout Us 

WHO WE ARE: Convey Health Solutions manages a myriad of administrative needs and make it easier for health plans to operate and provide valuable experiences for their members. How so? We focus on building specific technologies and services that uniquely meet the needs of government-sponsored health plans.

 

OUR MISSION: To improve health plan operations and elevate the customer experience.

 

OUR VISION: Empowering health plans to excel through technology, service and advisory experience.

 

OUR VALUES: Integrity First - Inspired Teamwork - Compliance Matters

 

 

Equal Opportunity Employer