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Quality Engineer

4 months ago

Gray, United States Enercon Technologies Full time

Summary:

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.


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


The skills you need to succeed:

  • You must have strong goal attainment orientation with team focus
  • 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


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 desirable
  • Advanced word processing (Microsoft Word), database (Access) and spreadsheet (Excel) skills