Quality Assurance Specialist

3 weeks ago


Marquette, Michigan, United States Resolve Surgical Technologies Full time
Quality Inspector Job Summary

Resolve Surgical Technologies is seeking a part-time Quality Inspector to support our production operations and achieve optimal product quality. The ideal candidate will have a strong understanding of quality control principles and be able to perform inspections, investigations, and documentation with accuracy and attention to detail.

Key Responsibilities:
  • Support production operations to achieve optimal product quality
  • Perform investigations for product nonconformance/issues and document exceptions in the CAPA system
  • Assist in performing, documenting, and training personnel for proper use of quality equipment
  • Operate inspection equipment, including vision systems, CMM, profilometer, etc.
  • Perform inspections and testing for conformance to specification, drawing, and inspection requirements
  • Accurately document results of inspections and testing, including nonconformance reporting when required
  • Review documentation for compliance to established procedures and GDP
  • Ensure all non-compliance issues associated with inspections are accurately reported
  • Perform routine AQL inspections and conduct 100% inspections as required
  • Sample, analyze, and monitor product quality in accordance with established procedures
  • Effectively communicate issues to Quality Engineering and/or operations
  • Perform documentation activities that adhere to cGMP and GDP
  • Utilize various measurement tools and instruments, such as calipers, scales, thickness gauges, force gauges, optical comparator, etc.
  • Perform inspection activities of printed materials against master documents for differences
  • Update release status of materials electronically to indicate acceptance or rejection, and communicate status to various departments
  • Perform programming of inspection equipment (i.e. Vision Systems and Digital Comparators)
  • Support Gage R&R's
  • Conduct Bioburden Endotoxin Testing

Education/Experience Required and/or Preferred:

Quality Inspector I:

High School diploma

One year experience in medical device or Quality Control environment preferred

6+ months of relevant coursework preferred



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