Quality Control Engineer

Xcorporeal, Inc. is growing! We are a Southern CA based medical device company developing innovative renal replacement devices for the commercial market. As part of our growth, we are currently seeking an experienced Quality Control Engineer to join our Irvine team.

In this role you will provide engineering support in the areas of design control, design and process verifications and validations.  You will also contribute to the development, implementation and maintenance of company’s quality systems policies and procedures.

To qualify for this opportunity you should possess the following:

·  Experience with QSR, Canadian and ISO 13485:2003 and IEC 60601 requirements

·  Good knowledge of validation principles including user requirements, functional specifications, IQ, OQ, PQ validation for facilities, systems, utilities, and equipment.

·  A thorough knowledge of the regulatory requirements for validation.

·  Good oral communications skills, detail orientation, problem solving ability and teamwork.

·  A minimum of 5 years of relevant experience in the medical device industry, or an equivalent combination of education and related experience.

·  A background in electro-mechanical assemblies preferred.

In return for your skills, Xcorporeal offers a competitive compensation and benefits package as well as the opportunity to participate in the development of an exciting new technology. For immediate consideration, please email your resume and cover letter, with salary requirements, to:  jobs@xcorporeal.com .

We are an equal opportunity employer