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
- 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.
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