Quality Engineer

Company : LanceSoft Inc

Country: United States

Location : Plano, Texas

Post: Sat, 28 Jan 2023 03:35:51 GMT

Expires: Sat, 25 Feb 2023 23:59:59 GMT

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—————————— Job Description ——————————

Job Title: Quality Engineer

Location: Plano, TX, 75024

Duration: 6 Months (Possible extension)

Shift: 8:00 AM to 5:00 PM

Supplier Spotlight Call Recap

Duties: Analyze files, mitigate line by line mitigation process, gap assessment and fill

Experience: 3-5 yrs work related experience, UMDR, Med Device, Regulated Environment, FMEA/ FMCA

Education: Bachelor s degree

Location: 100% On Site

Skill Sets: Organization, good communications skills, multi-task, self-sufficient, team player. Design and Develop Quality is a plus.

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.

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 product.

Manage corrective action and quality improvement activities.

Manage aspects of 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.