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Engineer, Quality

Temecula, CA 92591

Posted: 09/07/2023 Employment Type: Contract Job Category: Engineering Job Number: 579913 Is job remote?: No Country: United States

Job Description

This is for an Engineering position that will have a heavy emphasis on adherence to medical device regulations require a lot of writing and supporting areas of the manufacturing ancillary areas, such as warehouse, e-beam, chemical mixing & Laboratories.

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 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.

Previous experience:
3-5 years in any of the following:
The requirement is that the Quality Engineers at this site do need an engineering degree.
• Medical (or other highly regulated industry) Audit support experience
• Medical device complaint investigations
• Manufacturing line support
• Exhibit Excellent teamwork – ability to work with cross functional team across the world including upper management

Top 3 things that I’m looking for:
•Able to work onsite- Strong background with engineering fundamentals
• Excellent communication and investigating writing skills (CAPA)
• Understanding of or willingness to learn and work within highly regulated industry

Target pay: 38-39/hr
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