Quality Process Engineer

Actalent•Middlebury, CT

29d•$38 - $53•Onsite

About The Position

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

Requirements

3+ 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 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, with a good working knowledge of Excel.
Excellent communication and organizational skills working in cross-functional teams.

Nice To Haves

Proficient in GD&T, blueprint reading, quality management system, metrology, manufacturing process optimization & documentation.
Experience with engineering change orders and manufacturing design.

Responsibilities

Lead technical resource for Quality, RMA, 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, suggesting 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.
Manage ECO documentation release and Bill of Materials updates across multiple product lines.
Prepare documentation with a high degree of accuracy, completeness, and effectiveness.