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Quality Control Inspector II

2 months ago

Auburn, Massachusetts, United States Repligen Full time
Job Summary

We are seeking a highly skilled Quality Control Inspector II to join our team at Repligen. The successful candidate will be responsible for ensuring the quality of our products and processes, and will play a key role in maintaining our ISO 13485 Quality Management System.

Key Responsibilities
  • Inspecting and Auditing incoming materials and processes to ensure conformance to quality standards.
  • Performing Mechanical Inspections of machined parts based on drawing requirements using precision measuring tools.
  • Electronics Inspection to verify components to engineering records and documentation requirements.
  • Identifying and Documenting Results of inspections, and clearly communicating nonconformances to specified requirements.
  • Accessing and Interpreting Engineering Drawings, specifications, purchase orders, and standards to determine quality status.
  • Maintaining Quality Data Storage and providing QA floor support activities, including participating in cost-out activities and additional data collecting.
  • Identifying and Communicating Continuous Improvement Opportunities for the quality program for customers internal and external.
Requirements
  • High School Diploma or Two-year Technical Degree (ASME) or equivalent from an accredited technical institution.
  • Strong Mechanical Background with a minimum of 3 years of experience.
  • Familiarity with Medical Devices, Bioprocessing Equipment, Military, or Aerospace Industry.
  • Experience with ISO 9001, ISO 13485, AS9100, or Equivalent QMS Standards.
  • Demonstrated Use of Mechanical Inspection Hand Tools and CMM, FARO Preferred.
  • Basic Microsoft Office Tools (Outlook, Excel, Word).
  • Ability to Read/Interpret Blueprints and Diagrams.
  • Working Knowledge of GD&T.
  • Familiarity with ASME, BPE Codes.
  • Team-Oriented with Good Written and Verbal Skills.
What We Offer
  • Excellent Benefits Package, including Health Insurance, 401K, and Well-being Programs.
  • Competitive Salary and Bonus Structure.
  • Opportunities for Professional Growth and Development.