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