Senior Quality Technician
Holaira, Inc. - Plymouth, MN

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Position Summary:
This position is responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within new product development, manufacturing, or system/services support.

Responsibilities:

  • Assist in designing, building, and evaluation of test methods and inspection fixturing
  • Coordinate and perform inspection and testing of developmental product
  • Assist in writing, executing and documenting equipment, product, process, and test method verifications, qualifications, and validations and initiate related documentation changes.
  • Perform final product inspections against specification and procedural requirements.
  • Perform first article and incoming inspection of purchased components and inspection of production operations, including documenting inspection and test results.
  • Monitor and/or perform calibration and maintenance of all test equipment and fixtures
  • Document nonconformances as appropriate and assist in the resolution of nonconformances
  • Collect data, summarize, analyze, perform basic statistical analysis on, and document test results

Qualifications:

  • 2 year technical degree or equivalent course work
  • Minimum of 5 years’ experience in medical device or related field
  • Previous experience in assisting with verification and validation testing, test methods, inspections, and nonconforming material dispositioning
  • Knowledge of standards, FDA, and ISO 13485
  • Experience with metrology and measurement systems

Preferred Qualifications: (Optional)

  • Training in blueprint reading
  • Good communication and computer skills, including data analysis and report writing skills
  • ASQ CQT certification or equivalent
  • Experience with catheter based products
  • Experience with data analysis and statistical based approaches

Indeed - 17 months ago - save job