Junior Supplier Quality Engineer(medical device)

3 weeks ago


Westford, United States INTELLECTT INC Full time

Role:

Quality Engineer

Location:

Westford, MA - 1886

Duration:

8 Months

Job Description

The purpose of this position is to initiate medical device quality assurance activities. These activities must be in accordance with FDA Quality System Regulation, ISO13485 and other international standards. This position will also support device complaint investigation and failure analysis as required.

Essential Duties And Responsibilities

Develop incoming inspection processes and document incoming inspection activities. Provide in-process QA support to include inspection and document review. Complete final acceptance activities. Manage the sterilization process, including validations and product sterile loads. Track nonconforming material and lead Material Review Board (MRB) efforts. Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing. Lead complaint investigations on returned products. Manage corrective action and quality improvement activities. Manage aspects of the internal quality system relating to receiving inspection, calibration, MRB, etc. Assist in the performance of quality system internal auditing. Support quarterly management review meetings. Establish, monitor and evaluate quality system metrics.

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