Quality Engineer I

3 weeks ago

Temecula, United States Bioethic Full time

Our client is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional’s, and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries. This position works out of our Temecula, California location in our AVD Vascular business unit. Our solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. Our products are also utilized by laboratory management to ensure efficiency in their operations. Our client provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. Job Summary:

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. This job description will be reviewed periodically and is subject to change by management.

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