Quality Engineer

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Description Summary
Responsible for sustaining and improving the processes required to manufacture a medical device under the guidance of an ISO 13485 Quality Management System, FDA requirements, and other international standards. Quality Engineer will be a member of the engineering team and report to the Manufacturing Engineering Manager.

Job Description
POSITION: QUALITY ENGINEER
Description Summary
Responsible for sustaining and improving the processes required to manufacture a medical device under the guidance of an ISO 13485 Quality Management System, FDA requirements, and other international standards. Quality Engineer will be a member of the engineering team and report to the Manufacturing Engineering Manager.

Primary 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.

Knowledge And Skill 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 Solid Works 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. Compensation is dependent on experience and education. Benefits include a matching 401K, health, dental, vision and paid time off.

O2 Concepts is an equal opportunity employer and welcomes applications from diverse candidates.