Senior Quality Inspector

3 weeks ago

Bedford, United States InfraReDx Full time

Responsible for prioritizing inspections, conducting testing/measurements, and data collection. The Senior Quality Inspector must apply the methods and procedures prescribed in the Quality System. Must be able to generate and maintain data for the control of documentation, effectively report information, and accurately respond to questions from team members. Additional responsibilities include assessing and communicating non-conformances, and working with internal parties to drive corrective actions (where necessary). Primary purpose is to ensure all purchased materials meet specification. Work Schedule: Monday - Friday, 8:00am - 5:00pm.

Responsibilities:

  • Responsible for inspection of medical device materials/products through use of various inspection instruments such as micrometers, calipers, vision system(s) and other measuring equipment.
  • Inspect incoming raw materials, parts and assemblies.
  • Complete, review and maintain acceptance documentation.
  • Provide assistance when analyzing data or developing inspection criteria.
  • Participate in and execute First Article Inspection process for new or updated components/assemblies.
  • Observe, monitor, and maintain equipment to ensure conformance to requirements/specifications. Coordinate calibration activities as required.
  • Generate non-conformance material reports (NMRs) in quality database when necessary.
  • May participate in Material Review Board (MRB) Meetings to support discussion of non-conforming materials and disposition, as requested.
  • Record and evaluate quality test data, both internally and externally.
  • Read and interpret engineering diagrams and blueprints.
  • May also act in material receiving role with Purchasing department.
  • Contribute towards continuous improvement activities.

Requirements:

  • 8+ years QC inspection experience, with an emphasis on incoming inspection within the medical device or life sciences industry.
  • High School Diploma or GED equivalent, required.
  • Experience with high quality precision machined parts, basic mechanical measurements and methods.
  • Ability to execute job function with little to no assistance.
  • Knowledge and experience in performing mechanical and electronic inspection.
  • Ability to understand work instructions and interpret mechanical and assembly drawings.
  • Working knowledge of Geometric Dimensioning and Tolerancing Methods (GD&T).
  • Ability to read, interpret, and apply supplier inspection and test reports.
  • Ability to learn, understand, and perform inspection and testing of optical components, electromechanical assemblies, and other devices through the use of company test procedures and test set-ups, recording inspection and test results as required.
  • Familiarity with equipment control methods, such as calibration, maintenance, and qualification.
  • Ability to read, interpret, and apply sampling and sampling plans.
  • Prior experience with statistical analysis, such as SPC, comparative testing, reliability methods is a plus.
  • Ability to work effectively in a team environment, and communicate with various levels throughout the organization.
  • Knowledge of cGMP and ISO 13485.
  • Working knowledge of MS Word, Excel and Outlook.

PI0b0f7f09d85d-8327

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