Job Description

BEPC INC IS LOOKING FOR A QUALITY ASSURANCE (QAE) VALIDATIONS ENGINEER IN IRVING, CA! CONTRACT W2 PERIOD: 6 MONTHS CONTRACT WITH POSSIBILITIES FOR EXTENSIONS PAY & BENEFITS: $50/HR. +MEDICAL, DENTAL, VISION AND LIFE INSURANCE

QUALITY ENGINEER JOB DESCRIPTION:

QUALITY ENGINEER DUTIES AND RESPONSIBILITIES

Quality Engineers help create solutions as part of an engineering team. They work to find defects, determine the causes of those defects and provide solutions to defected problems. The Quality Engineer has several other duties and responsibilities, some of which include:

• Determining quality improvement factors
• Implementing methods to inspect, test and evaluate the reliability of manufacturing processes, products and production equipment
• Making sure processes adhere to quality standards
• Preparing reports by collecting, analyzing and summarizing data
• Working in accordance with deadlines for delivery of products or software

SUMMARY/OBJECTIVE

The Quality Engineer position works closely with the engineering team and customers to launch new products and processes in a Medical Device manufacturing setting. In addition, this position leads corrective action and continuous improvement activities in collaboration with the company’s quality vision and strategy.

ESSENTIAL FUNCTIONS

· Team member of medical device validation team with Quality Assurance Engineering responsibilities

· Ensure validation documentation meets all requirements per GMP standards.

· Coordinates, reviews, and submits First Articles, PPAPs, and sample parts for customer approval.

· Handles internal and external quality issues and drives timely and effective corrective actions.

· Implements, maintains, and audits company quality systems.

· Communicates quality issues to production personnel through work aids.

· Develops control and inspection plans for operations as well as incoming materials and components.

COMPETENCIES

· Communication Proficiency

· Decision Making

· Initiative

· Problem Solving/Analysis

· Results Driven

· Technical Capacity

· Thoroughness

SUPERVISORY RESPONSIBILITY

This position has no supervisory responsibilities.

WORK ENVIRONMENT

The Quality Engineer has frequent interaction with other functional roles and departments (e.g. project engineering, automation, tool engineering, and processing). Most work is performed in an office environment, yet this position also will collaborate with production staff in manufacturing areas. While performing the duties of this job, the employee must wear appropriate personal safety protection equipment.

REQUIRED EDUCATION AND EXPERIENCE

· Bachelor’s degree in an engineering field

· Prior use of measuring tools such as: calipers, micrometers, go/no go gauges, and height and depth gauges

· 1-3 years of experience in a quality role; medical device preferred

· ISO13485 regulation understanding and experience (medical devices)

· Strong knowledge of statistics

· Six Sigma Lean Certification belts a plus

BEOCS