Quality Engineer II

Quality EngineerInsight Global is seeking a Quality Engineer to support manufacturing operations and Quality Management System activities within a medical device/component manufacturing environment. This individual will be responsible for supporting QMS effectiveness, maintaining compliance with ISO 13485:2016 standards, and partnering cross-functionally with quality, engineering, and production teams to support product quality and operational performance.The Quality Engineer will provide hands-on shop floor support, assist with root cause analysis, support CAPA and nonconforming material processes, and help drive continuous improvement across quality and manufacturing operations. This role requires strong technical problem-solving skills, experience working within regulated manufacturing environments, and the ability to support day-to-day quality activities in a fast-paced onsite setting.Location: Norwood, MA Schedule: 5 days/week onsite Employment Type: Full-TimeResponsibilities -Support the maintenance and effectiveness of the Quality Management System in alignment with ISO 13485:2016 requirements. -Provide shop floor support for production troubleshooting, root cause analysis, and quality-related manufacturing issues. -Support Red Cart processes, Gemba Walks, and day-to-day manufacturing quality activities. -Own and support Corrective and Preventive Action (CAPA) activities. -Support equipment qualification and validation processes, including IQ, OQ, and PQ documentation. -Partner with engineering teams to draft, review, and execute protocols. -Own and support Nonconforming Material processes and lead MRB activities where applicable. -Perform First Article Inspections in partnership with quality control personnel. -Create and execute Measurement System Analysis activities, including Gage R&R, where applicable. -Support day-to-day operational initiatives focused on KPI improvement and business objectives. -Support Approved Supplier List evaluations, reporting, and supplier feedback activities. -Create and revise Standard Operating Procedures, Work Instructions, and Forms. Provide input into FMEAs and risk management activities. -Perform product quality inspections, equipment calibration, and training activities as needed. -Support additional quality and manufacturing responsibilities as assigned.Salary Range: $100,000-$110,000