Medical Device Quality Engineer — Validation & Compliance

Insight Global; Raynham (MA); On-site; USD 94,000 - 112,000; Full time

Benefits offered by this job

Health insurance

401(k) after 90 days

Paid time off

Job summary

Insight Global is seeking a Quality Engineer to support a medical device client in Raynham, MA. This onsite role collaborates with Engineering, Manufacturing, R&D, and Quality to drive compliance, validation, risk management, and continuous improvement in a regulated environment.

The successful candidate will have 3–5+ years in quality engineering, knowledge of FDA QSR, ISO 13485/9001, and experience with product/process validations and risk assessments.

Qualifications

• Bachelor's degree in a related engineering field.
• 3-5+ years of quality engineering experience in a regulated industry.
• Experience with FDA QSR, ISO 13485 and ISO 9001.

Responsibilities

• Represent Quality on cross-functional teams for product launches.
• Develop, execute, and document validation protocols for products, processes, test methods, and software systems.
• Support revalidation after engineering changes, deviations, system upgrades, or material changes.
• Perform statistical analysis to support validation and establish process controls.
• Conduct quality risk assessments and apply risk management methodologies.
• Collaborate with R&D and Engineering to define CTQ characteristics.
• Lead Design for Inspection initiatives and reduce human error.
• Ensure compliance with FDA QSR, ISO 13485/ISO 9001 and internal quality system requirements.
• Support CAPA activities, investigations, and root cause analyses.
• Partner with manufacturing to resolve quality issues and improve production efficiency.
• Provide quality oversight to meet timelines and quality objectives.

Skills

Quality engineering

Risk assessment

Root cause analysis

Statistical analysis

Cross-functional collaboration

Project management

Design for Inspection

Documentation & compliance

Education

Bachelor's degree in Mechanical/Industrial/Quality Engineering

Job description

Insight Global is seeking a Quality Engineer to support a medical device client in Raynham, MA. This onsite role collaborates with Engineering, Manufacturing, R&D, and Quality to drive compliance, validation, risk management, and continuous improvement in a regulated environment.

The successful candidate will have 3–5+ years in quality engineering, knowledge of FDA QSR, ISO 13485/9001, and experience with product/process validations and risk assessments.