Endologix, Inc

Staff Quality Engineer

Job ID
2017-1779
US-CA-Irvine
Category
Quality

Overview

Endologix develops and manufactures the latest innovations in endovascular aneurysm repair and sealing. We are a fast-moving, high energy organization. Employees are offered development opportunities and new responsibilities that might have taken them significantly more time in other organizations. Our commitment is to promise the development and refinement of skills while providing competitive compensation and benefits.

 

Provides support in the development and maintenance of company’s Quality Systems.  Plans and implements Quality Assurance programs designed to ensure continuous production 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.
  • Supports Quality Control activities (Production, Receiving Inspection, Finished Goods, and Calibration).  Helps to meet established schedules or resolve technical or operational problems.  Assist in supervisory activities of Quality Control personnel.
  • Perform non-conformance 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.  Coordinate the reporting and provide trend analysis for non-conformance incidences.
  • Determines equipment qualification, process validation, and product line design/modifications requirements.  Advises Manufacturing on installation and maintenance of inspection and testing procedures for raw materials, packaging materials, components and finished products.  Supports design transfer activities.
  • Works with Manufacturing to provide feedback to production personnel regarding accuracy of assembly procedures.  Works with Facilities to establish and maintain effective environmental monitoring systems.
  • Leads development of Risk Management documentation.
  • 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
  • Process Qualification (OQ/PQ) experience strongly desired
  • 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.

                                            

If you are a qualified individual with a disability or a disabled veteran, you have the right to request an accommodation if you are unable or limited in your ability to use or access our career center as a result of your disability. To request an accommodation, contact a Human Resources Representative at Endologix Global Headquarters at 949-595-7200 or Endologix Santa Rosa Facility at 707-543-8800

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