Quality Engineer

We are seeking Quality Engineers with strong hands-on experience troubleshooting electro-mechanical medical devices in a fast-paced manufacturing environment. This role is critical to supporting production lines, ensuring compliance, and driving continuous improvement in a regulated medical device setting.Key ResponsibilitiesProduction Line Support: Provide direct support to manufacturing operations, ensuring smooth production of medical devices.Troubleshooting: Perform hands-on diagnostics and repair of electromechanical systems, identifying root causes and implementing corrective actions.NCE Investigations: Lead non-conformance event investigations, develop containment strategies, and conduct risk assessments.CAPA & Risk Management: Execute corrective and preventive actions, ensuring compliance with FDA/GMP and ISO 13485 standards.Documentation Review: Review Device History Records (DHR) and quality documentation for accuracy and compliance.Collaboration: Partner with Manufacturing and Production Engineering teams to resolve quality issues and improve processes.Requirements:Proven experience as a Quality Engineer in the medical device industryStrong hands-on troubleshooting of electro-mechanical devicesExperience with NCE investigations, CAPA, containment, and risk assessmentsBackground in production/manufacturing supportKnowledge of DHR review and quality documentationElectrical engineering or electrical systems background preferredPrevious Medtronic experience is a huge plusPreferred Qualifications:Experience with Medtronic or similar medical device companiesBackground in FDA/GMP regulated environmentsStrong familiarity with medical device manufacturing processesAdditional Information:100% On-Site role in Newark, NJWeekend/Saturday support required based on production needsImmediate interview and quick onboarding process