Senior Quality Engineer, Medical Devices (Digital Transformation)

Fusion Life Sciences Technologies LLC; Bridgewater (MA); On-site; USD 100,000 - 140,000; Full time

Job summary

Fusion Life Sciences Technologies LLC is seeking a Senior Quality Engineer to support a Digital Transformation project in the Medical Device sector. The role focuses on leading quality representation, validation and risk management across cross‑functional teams, ensuring FDA QSR and ISO compliance while enabling new technologies in production.

The ideal candidate has 3–5+ years in regulated quality engineering, hands-on validation experience, and strong problem‑solving skills to drive quality

Qualifications

• Bachelor's degree in a relevant engineering field.
• 3–5+ years of quality engineering in a regulated setting.
• Medical Device industry experience preferred.
• Experience introducing and implementing new technologies in manufacturing.
• Strong knowledge of validation, risk management, statistics, and FDA/ISO requirements.

Responsibilities

• Represent Quality on cross‑functional project teams for new technologies in production.
• Develop, execute, and review validation protocols for test methods, products, processes, and software.
• Ensure validation activities meet procedures and regulatory requirements.
• Coordinate revalidation after engineering changes or material changes.
• Apply statistical analysis to establish inspection requirements and controls.
• Perform quality risk assessments and mitigate potential risks with new tech.
• Collaborate to define CTQ characteristics and inspection requirements.
• Lead Design for Inspection activities for NTI projects to improve inspection effectiveness.
• Ensure compliance with FDA QSR, ISO 13485, and ISO 9001 quality systems.
• Support root cause analysis, problem solving, and investigations.
• Identify corrective actions and drive issue resolution.
• Provide troubleshooting for new technologies and existing processes.
• Identify opportunities to reduce compliance risks, scrap, and rework.
• Maintain quality documentation and ensure activities follow procedures.

Skills

Quality engineering

Statistical analysis

Risk management

Root cause analysis

Project management

Cross-functional collaboration

FDA QSR/GMP

ISO 13485 / ISO 9001

Validation

Verification

Education

Bachelor's degree in Mechanical Engineering

Job description

Fusion Life Sciences Technologies LLC is seeking a Senior Quality Engineer to support a Digital Transformation project in the Medical Device sector. The role focuses on leading quality representation, validation and risk management across cross‑functional teams, ensuring FDA QSR and ISO compliance while enabling new technologies in production.

The ideal candidate has 3–5+ years in regulated quality engineering, hands-on validation experience, and strong problem‑solving skills to drive quality