Quality Engineer II

Insight Global; Norwood (MA); On-site; USD 100,000 - 110,000; Full time

Job summary

Insight Global is seeking a Quality Engineer to support manufacturing operations and QMS activities in a medical device environment. You will help maintain ISO 13485 compliance, assist with CAPA, nonconforming material, and root cause analysis on the shop floor.

Located in Norwood, MA, this onsite role requires hands-on problem solving, cross-functional collaboration with quality, engineering, and production teams, and day-to-day quality activities in a fast-paced setting.

Qualifications

• 5-8+ 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.

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.

Skills

Quality engineering

ISO 13485

CAPA

Gage R&R

GD&T

Documentation

Education

Bachelor's degree in related field

Tools

Minitab

QMS software

MS Office Suite

ERP systems

Job description

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: $100,000-$110,000

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and Requirements

• 5-8+ 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. -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.