Quality Engineer

Quality, 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.  

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 manage the incoming inspection department
  • 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)
  • You will lead internal quality system audits
  • You will lead audits from regulatory and safety agencies, customers, and registrars
  • You will participate in design reviews as needed

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


  • Enercon Technologies offers a competitive benefits package.