Quality Engineer Job in Burlington 01803, Massachusetts US
ConforMIS, Inc. is a privately held medical device company based in Massachusetts.
It was founded in 2004 to provide dramatic advancements in patient care by utilizing imaging technology to create personalized, patient-specific implants and instrumentation.
TITLE: Quality Engineer REPORTS TO: Director, Quality Assurance Job Summary: This position is responsible for quality engineering/quality assurance activities.
This includes interpretation and implementation of quality standards to product development and routine manufacturing activities.
The role is also accountable for continuous improvement of the companys quality system in accordance with applicable regulatory requirements.
Essential Duties and Responsibilities: · Manage the product complaint handling process, assembling pertinent documentation for investigation of reported complaints in collaboration with the responsible engineer.
· Analyze complaint trends and determine the need for corrective actions / Preventive actions (CAPA) as appropriate· Determine need for MDRs /Vigilance reporting; perform and notifications as necessary · Manage the Corrective and Preventive Action System; upgrade as required to improve the effectiveness of the quality system
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