Quality Engineer

Required Skills & Experience

-3 to 5 years of quality engineering experience within medical device, medical component, or regulated manufacturing environments. -Strong understanding of Quality Management Systems and ISO 13485:2016 requirements. -Experience with nonconforming material processes, calibration, CAPA, root cause analysis, and related quality systems. -Experience supporting equipment qualification, validation, and protocol execution. -Proficiency with metrology tools such as hand measurement devices, vision systems, microscopes, non-contact devices, and/or profilometers. -Ability to read and interpret drawings, GD&T, and blueprints. -Strong written and verbal communication skills. -Proficiency with Microsoft Office Suite, including Word, Excel, PowerPoint, and Visio. -Experience navigating ERP systems for data entry and retrieval. -Bachelor’s degree in a related field.

Nice to Have Skills & Experience

-Experience supporting customer, registrar, or FDA audits/inspections. -Experience with QMS software and/or Minitab. -Ability to speak Portuguese. -Valid Class D Driver’s License.

Job Description

Insight 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-Time

Responsibilities

-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: $80,000-$90,000