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Finish Line Staffing Services
Published
September 1, 2022
Location
Burlington, MA
Category
Job Type

Description

Our client, a leading innovator in 3D printed spinal interbody fusion implants and instrumentation, has an immediate opening for a Quality Engineer.

Responsibilities:

  • Support QMS deliverables, including but not limited to: customer complaints, field safety corrections/removals, risk analysis, NCMR, CAPA, and process/equipment verification/validation/maintenance
  • Support Design Assurance activities through full product lifecycle including design controls documents, risk assessments, design reviews, design verification and validation, test plans and reports, and post-market surveillance
  • Maintain Design History Files, ensuring compliance with QMS processes and applicable
    regulatory standards. Remediation of design control documentation for EU MDR 2017/745 & CE Mark compliance as needed.
  • Support the design and document change control processes
  • Support supplier selection, qualification, and monitoring activities to ensure supply chain
    readiness and on-going performance
  • Lead investigations of out of specification situations to determine if there is impact to
    released product. Write technical reports in support of NCMR investigations, CAPAs, and
    containment activities
  • Support internal and external Quality Audits as needed to ensure compliance to applicable regulatory standards and company requirements
  • Support regulatory filings, including but not limited to: 510(k) / CE Marking technical file
    submissions, FDA Medical Device Reporting, EU Vigilance Reporting, and annual
    registrations

Requirements:

  • Minimum of 3 years working within a Medical Device quality organization
  • Bachelor’s Degree or higher (Engineering or life science degree preferred), or equivalent experience
  • Knowledge and experience with FDA Quality System Regulations, ISO 13485 Quality System Standard, ISO 14971 Risk Management, and other applicable regulations
  • Experience with EU Medical Device Regulation 2017/745 a plus
Apply
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