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Quality Engineer - Green Card/Citizen Required for this Position

Gray, ME
This position will be an integral part of the maintenance and improvement of the company’s quality management systems adherence to ISO and Regulatory requirements.  The candidate that fills this position will take a lead role in the identification and execution of problem-solving and improvement activities.

Functions & Responsibilities

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

Job Requirements

  • Strong problem-solving skills
  • Strong goal attainment orientation with team focus
  • Project/ task management skills
  • Ability to work in environments experiencing routine and rapid change
  • Excellent organization and decision making skills
  • Strong mentoring and leadership skills
  • Self-starter, possessing high degree of self-motivation

Educational Requirements

  • 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) skill
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