Quality Assurance Specialist

6 days ago


Middlebury, Connecticut, United States O2 Concepts, LLC Full time
Job Summary

We are seeking an experienced Quality Assurance Specialist to join our team at O2 Concepts, LLC. As a key member of the manufacturing engineering team, you will play a crucial role in ensuring the quality and reliability of our medical devices.

Key Responsibilities:
  • Lead technical resource for Quality, RMA and Technical Support.
  • Plan, execute and oversee component inspection and testing process to verify conformance with specifications.
  • Create and revise incoming inspection documentation.
  • Work collaboratively with Quality team members to manage the NCR process including documentation, supplier communication, product returns and rework, SCAR root cause investigations and issue resolution.
  • Initiate and rationalize engineering changes from nonconforming component issues, suggest changes for approval or rejection.
  • Develop design recommendations to improve product reliability and performance.
  • Develop, test, and implement design changes as well as coordinate with suppliers and manufacturers to ensure smooth implementation.
  • Provide technical resource regarding equivalency in value engineering and analysis for current components and future product development projects.
  • Manage Bill of Materials across multiple product lines.
  • Prepare and review documentation with a high degree of accuracy, completeness, and effectiveness.

Requirements:

  • 5+ years of experience in a manufacturing environment required.
  • Bachelor's degree in Engineering (Mechanical, Manufacturing or Biomedical) required.
  • Working knowledge of AS 9100, ISO 9001 and/or ISO 13485 preferred
  • Proficient In CAD with SolidWorks expertise preferred.
  • Knowledge of manufacturing operations, process verification and validation, geometric dimensioning and tolerancing (GD&T) including the ability to create and understand prints and specifications.
  • Ability to organize and prioritize workflow across multiple projects to meet established time frames and schedules.
  • Mechanically inclined with an affinity for tools and measuring equipment.
  • Proficient in Microsoft Office, a good working knowledge of Excel a must.
  • Excellent communication and organizational skills working in cross-functional teams.

This is an exempt; full-time position with a salary range of $120,000 - $150,000 per year, depending on experience and education. Benefits include a matching 401K, health, dental, vision and paid time off.



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