Quality Engineer

Full Time

As a Quality Engineer for the organization you will be an integral part of the maintenance and improvement of the company’s quality management systems adherence to ISO and Regulatory requirements.  You will take a lead role in the identification and execution of problem-solving and improvement activities.

Functions & Responsibilities

In the role of Quality Engineer

  • You will lead CAPA activities and non-conformance investigations
  • You will develop and lead implementation of continuous improvement plans
  • You will lead supply chain quality management activities including audits and vendor CAPA’s
  • You will develop and lead internal quality improvement plans
  • You will participate in activities to ensure manufacturing processes are properly validated and in compliance with company, ISO, and regulatory requirements
  • You will participate in the development of Failure Mode and Effects Analysis (FMEA)

Job Requirements

The skills you need to succeed:

  • You must have strong problem-solving skills
  • You must have strong goal attainment orientation with team focus
  • You must have project/ task management skills
  • You must have the ability to work in environments experiencing routine and rapid change
  • You must have excellent organization and decision making skills
  • You must have strong mentoring and leadership skills
  • You must be a self-starter, possessing high degree of self-motivation

Educational Requirements

Education and experience of a successful candidate:

  • Bachelor’s degree in a related engineering discipline
  • 4+ years related experience in the development and maintenance of quality management system and documentation control processes and procedures
  • Related experience in an FDA regulated medical device company is strongly desired
  • Strong working knowledge of FDA medical device regulations, and ISO 13485 requirements in quality management systems and documentation control
  • Experience with printed circuit board assembly and test highly desirable
  • Experience implementing Lean manufacturing and/or Six Sigma projects preferred
  • Advanced word processing (Microsoft Word), database (Access) and spreadsheet (Excel) skills

Benefits

  • Enercon Technologies offers a competitive benefits package.