QUALITY ENGINEER

Job Description

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

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.