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Quality Engineer

Wilmington, DE

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Description

Our client has an immediate need for an experienced Quality Engineer.  This is a contract to perm position.

 

The Quality Engineer is responsible for maintaining Quality Management System processes and documentation. As a Quality Engineer, you will also be supporting the Product Development and Operations Teams in the design, production, and servicing of medical and veterinary devices throughout their product life-cycle from concept to post-market.

 

Responsibilities

 

  • Design and implement methods for process control, process improvement, testing and inspection
  • Develop, execute, and analyze quality reporting measures
  • Participate in internal and external quality audits
  • Establish (define, document, and implement) and maintain quality system policies and procedures
  • Evaluate product and process non-conformances using a risk-based approach
  • Identify defect trends and systematic issues through the analysis of quality problem reports and service order data
  • Perform thorough investigations of customer complaints and product malfunctions
  • Serve as document control within the electronic document management system
  • Provide support for various design control processes including risk management, usability engineering, change management and post market surveillance
  • Facilitate timely closure of corrective and preventive actions
  • Assist in generation of training materials and maintaining training log/matrices
  • Support receiving inspection activities and supplier performance evaluations

Job Requirements

Qualifications

 

  • Bachelor's degree or equivalent in Mechanical, Electrical, or Manufacturing Engineering
  • 1 to 2 years of experience in medical device industry or other regulated manufacturing setting
  • Strong knowledge of quality systems, documentation and methodologies (GMP, ISO13485, ISO9001, etc.) Desired
  • Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA)
  • Experience driving support to quality processes such as post market surveillance, CAPA, change management, and risk management
  • Experience transitioning new products to manufacturing
  • Experience with hands-on product design, test method, process, and equipment validations
  • Understanding of the fundamentals of global medical device regulations

 

Essential Competencies

 

  • Quality standards and philosophies
  • Statistical analysis
  • Risk management
  • Product and process control planning
  • Root cause analysis
  • Internal/supplier auditing Required Education & Experience
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