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Quality Assurance

Wallingford, CT

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Description

Anticipated Start Date:  ASAP

Hours of Work:  40 hours per week 2:30pm – 11pm

 

POSITION SUMMARY

Perform a variety of quality testing and inspection on medical devices.

 

Essential Functions:

  • Perform incoming inspections of materials and purchased items.
  • Perform in-process and final inspections, including packaging testing.
  • Test materials to assure quality standards and specifications are met. 
  • Identify and document nonconforming (rejected) materials.
  • Perform various material handling duties such as moving and lifting material to supply the variety of   stations needed for production.
  • Perform a variety of general housekeeping duties necessary to maintain a clean and orderly work area.
  • Assist with the tracking, boxing, labeling, and recordkeeping related to retain samples.
  • Assist with filing of quality documents (such as supplier batch records and Device History Records).
  • Enter data and release materials and products in electronic ERP/MRP computer system.
  • Other responsibilities as needed.
  • Occasional overtime may be required.
  • Must be flexible to work occasional weekends and cover different shifts as needed.

Job Requirements

QUALIFICATIONS/EXPERIENCE REQUIREMENTS

  • High School Diploma/GED required
  • Must be able to lift at least 25 lbs.
  • Experience in Quality Inspection, Quality Testing, and Receipt of Materials.
  • Experience working in a regulated environment (FDA GMP, ISO, etc).
    • Strong interpersonal skills, along with the ability to work individually as well as part of the team.       English is mandatory
    • Must be computer literate, proficient with working with computers, and have experience working with    a variety of computer systems (MRP/ERP systems experience preferred).
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