QUALITY ENGINEER

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