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Biomedical Search
Published
January 19, 2023
Location
Burlington, MA
Category
Default  
Job Type

Description

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

Responsibilities:

  • Oversee QMS deliverables, including but not limited to: customer complaints, field safety corrections/removals, risk analysis, NCMR, CAPA
  • Support the design and document change control review and approval processes
  • Lead supplier selection, qualification, and monitoring activities to ensure supply chain readiness and on-going performance
  • Support planning, execution, and maintenance of relevant process verification and validation test plans and reports, including routine sterilization, biological, packaging, and supplier validation studies
  • Support quality inspection of incoming product (receiving, in process, finished goods) to ensure compliance to specifications
  • Lead investigations of out of specification situations to determine if there is impact to released product
  • Provide technical support and perform the revision or implementation of the documentation of systems, including procedures (SOPs), work instructions, and forms
  • Manage internal and external Quality Audits as needed to ensure compliance to applicable regulatory standards and company requirements
  • Responsible for identifying risks and communicating gaps for process/systems
  • Other duties as assigned by the VP of R&D or CEO

Requirements:

  • Minimum of 5-7 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
  • Strong analytical, critical thinking, and interpersonal communication skills
  • Experience in a start-up or small company environment a plus
  • Previous experience interacting with FDA, ISO, and other regulatory agencies a plus
  • CQA or other lead auditor certification (ISO 13485) a plus
  • Proficient in the use of the following software: Excel, Word, Powerpoint, Google Drive Suite, Gmail
  • Up to 10% overnight travel may be expected
Apply
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