Quality Engineer – Medical Device

Quality Engineer – Medical Device

Under the direction of the Director of Quality, the Quality Engineer will be responsible for Design Verification/Validation, Process Validation and Quality Management System (QMS) documents in accordance with ISO 13485 and international standards. Will also perform
internal and external audits and write technical documents such as user manuals and installation instructions

Principal Responsibilities:

  • The Quality Engineer must have 5-8 years of quality experience in a medical device environment
  • Demonstrated ability to write Quality System procedures and develop appropriate assembly other technical documents
  • Understands and ensures compliance with appropriate standards, Quality System Regulations,
    ISO 13485 and other international regulations.
  • Perform internal audits of the effectiveness of QMS processes and assist with external audits by as required. Audit suppliers and their processes using ISO 13485 requirements
  • Will write, execute and review design verification/validation protocols, analyze results and prepares summary reports. Will manage the ECO and BOM process.
  • Overall responsibility for Design Validation, and Process Validation
  • Review CAPA(s) for appropriate content and assist in continuously improving the CAPA process and compliance to all applicable regulations

Education/Qualifications:

  • BS in Quality Engineering and 5-8 years experience in a medical device development
  • Experience working with large scale capital equipment is a plus
  • ASQ certifications – Audit certification is a desired

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