Sr. Manufacturing Quality Engineer (3243)

MEVION MEDICAL SYSTEMS INC•Littleton, MA

2d•$120,000 - $135,000•Onsite

About The Position

The Senior Manufacturing Quality Engineer is responsible for providing quality engineering support for the manufacturing and installation functions in accordance with the Mevion Quality Management System and applicable regulatory requirements.

Requirements

Bachelor’s degree in a technical discipline (Mechanical, Electrical Engineering or related)
5+ year experience in Manufacturing / Operations Quality for Medical Devices
Experience leading non-conformance handling processes and Manufacturing Quality Improvements
Broad understanding of 21 CFR 820, ISO 13485, ISO 14971 and other relevant medical device regulations / standards

Nice To Haves

ASQ Certified Quality Engineer or other demonstrated experience using statistical tools and techniques preferred
Experience in devices with customer site installation requirements preferred
DMAIC, DFSS Green/Black Belt Certification preferred
Familiarity with complex medical devices containing software preferred

Responsibilities

Participates in the investigation and disposition of product and process non-conformances
Supports CAPAs related to the area of responsibility
Interacts with cross-functional teams to resolve quality issues
Reviews and contributes to Process Validation (Planning, IQ/OQ/PQ, Gauge R&R, etc.)
Supports the development, validation and implementation of test methods
Supports internal and external audits
Applies statistical tools and techniques to analyze data
Ensures Quality System compliance for area of responsibility
Performs and leads risk assessment and risk control measures in support of manufacturing and installation
Reviews and approves Document and Engineering Change Orders related to manufacturing and service
Maintains Risk Management Documentation for product(s)
Other activities related to Operations and QA as determined by Management