Device Quality Manager

6 days ago


Middlebury, Connecticut, United States O2 Concepts, LLC Full time
About the Job

O2 Concepts, LLC is seeking an experienced Device Quality Manager to join our team. The successful candidate will be responsible for managing the quality assurance activities, ensuring compliance with regulatory requirements and industry standards.

Responsibilities:
  • Manage the quality assurance activities, ensuring compliance with regulatory requirements and industry standards.
  • Lead technical resource for Quality, RMA and Technical Support.
  • Develop and maintain procedures, work instructions and checklists to ensure effective quality management.
  • Conduct audits and inspections to ensure compliance with regulatory requirements and industry standards.
  • Identify and mitigate potential quality risks, implementing corrective actions as needed.

Requirements:

  • 5+ years of experience in a quality management 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.

This is an exempt; full-time position with a salary range of $130,000 - $170,000 per year, depending on experience and education. Benefits include a matching 401K, health, dental, vision and paid time off.



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