QC Inspector II

Elevaris Medical DevicesWilmington, MA
$27 - $29Onsite

About The Position

The desired candidate will have prior Quality Inspector experience, preferably working in a medical device company. Specific experience and responsibilities will include, but not limited to performing incoming mechanical inspections, various functional testing, final inspections and support of calibration and equipment programs.

Requirements

  • High School Diploma or equivalent
  • 2+ yrs. in a similar quality inspection role

Nice To Haves

  • Prior medical device experience a plus
  • Knowledge of FDA Quality System requirements and ISO 13485 requirements a plus
  • Excellent organizational, verbal, written communication, and problem-solving skills.
  • Possess above-average interpersonal skills demonstrating the ability to work with others in a professional, positive, and collaborative manner.
  • Ability to work in a fast-paced environment and to meet tight deadlines.
  • Willingness to learn, possess a can-do attitude, and motivated to succeed and grow.
  • Ability to multi-task with strong attention to detail
  • Proficient in MS Office Suite, and of Statistical Process Control Practices

Responsibilities

  • Perform incoming mechanical inspection on a variety of medical devices including custom needle assemblies, stainless steel surgical instruments, scalpel blades, glass LOR syringes, trocars, etc.
  • Interpret engineering drawings and blueprints to determine inspection points and required product specifications.
  • Use a variety of instruments for visual, dimensional, functional, and destructive testing (micrometer, caliper, video measuring equipment, Lloyd materials tester, pin gages, etc.)
  • Conduct a variety of functional testing i.e. (pull, peel, burst, penetration)
  • Generate Certificates of Conformance for accepted material prior to release of product
  • Perform final inspection on packaged material ready to be shipped by confirming shipping documentation and product labeling.
  • Release material from Pending QA Inspection location to packaging area once the material has been inspected, accepted, and a COC has been generated.
  • Support the calibration program
  • Support equipment PM program
  • Support the temperature logging program with data collection and review of information
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