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Staff Quality Engineer

Company: Endologix, Inc.
Location: Irvine
Posted on: May 16, 2020

Job Description:

OVERVIEW

Provides support in the development and maintenance of company s Quality Systems. Plans and implements programs designed to ensure continuous sustaining and development of products consistent with established standards by performing the following duties:

RESPONSIBILITIES

* Establishes and maintains Quality Assurance programs, procedures, and controls. Ensures that performance and quality of products conform to established company and regulatory standards.

* Leads development of Risk Management documentation.

* Manages Design Assurrance activities (Development, Risk Management Reports, standard reviews and agining studies). Helps to meet established schedules or resolve technical or development problems. Assist in supervisory activities of Quality technicians.

* Perform investigations to determine root case. Assign and ensure completion of corrective and preventive actions. Complete investigations in a timely manner to ensure customer service levels are maintained.

* Determines equipment qualification, process validation, and product line design/modifications requirements.

* Advises on installation and maintenance of inspection and testing procedures for raw materials, packaging materials, components and finished products. Supports design transfer activities.

* Works with R&D to provide feedback regarding accuracy of development procedures.

* Assists in conducting and documenting process and system audits using specific regulations and company procedures as audit standards.

* Promotes and organizes training activities related to product quality, cost, reliability, and regulatory compliance. Develops strategies to ensure continuous improvement in the ability to design and manufacturing quality products.

* Maintains an up to date knowledge in the techniques of Quality Assurance/Quality Control and in the company products and process technologies.

* Perform other duties as assigned by supervisor

QUALIFICATIONS

* Strong communication and organization skills required

* Good judgment skills within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

* Flexibility to handle multiple tasks and meet timelines. Normally receives minimal instructions on routine work, general instructions on new assignments.

Experience:

* Eight years with a Bachelor s degree

* Six years with a Master s degree

* Three years with a PhD

Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

Keywords: Endologix, Inc., Irvine , Staff Quality Engineer, Engineering , Irvine, California

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