Senior Quality Engineer

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

Senior Quality Engineer – Digital Transformation

Primary Location: Bridgewater, MA

Job Type: Contract – Up to 12 Months

Position Summary

We are seeking an experienced Senior Quality Engineer to support a Digital Transformation project within the Medical Device industry. The Senior Quality Engineer will represent Quality as part of a cross‑functional team and support the successful introduction and implementation of new technologies into production while ensuring the highest standards of quality, regulatory compliance, and project execution.

The ideal candidate will have 3–5+ years of Quality Engineering experience within a regulated industry- Medical Devices, along with strong expertise in validation, verification, risk management, statistical analysis, and FDA/ISO requirements.

Key Responsibilities

• Represent Quality as a member of cross‑functional project teams to ensure successful delivery of new technologies into production while maintaining quality, compliance, and project timelines.
• Develop, compile, execute, and review validation protocols for new test methods, products, processes, and software.
• Ensure validation activities are implemented in accordance with established procedures and regulatory requirements.
• Perform and coordinate revalidation activities resulting from engineering changes, deviations, system upgrades, or material changes.
• Apply statistical analysis as part of validation activities and use results to establish appropriate inspection requirements and production controls.
• Conduct Quality Assurance risk assessments and risk analyses to identify and mitigate potential risks associated with new technology development and implementation.
• Collaborate with R&D to identify, define, and document Critical-to-Quality (CTQ) characteristics and associated inspection requirements.
• Lead Design for Inspection (DFI) activities for New Technology Introduction (NTI) projects, with a focus on improving inspection effectiveness and reducing human error.
• Ensure compliance with applicable quality systems and regulatory requirements, including FDA Quality System Regulation (QSR) and ISO 13485/ISO 9001 requirements.
• Provide technical support for root cause analysis, problem‑solving, and complaint investigations.
• Work cross‑functionally to identify effective corrective actions and drive resolution of quality issues.
• Support troubleshooting and problem‑solving for both new technologies and established production processes.
• Identify opportunities to reduce compliance risks, scrap, rework, and process inefficiencies.
• Maintain appropriate quality documentation and ensure project activities are completed in accordance with established quality procedures.

Required Qualifications & Experience

• Bachelor's degree or equivalent qualification in Mechanical Engineering, Industrial Engineering, Quality Engineering, or another relevant technical/engineering discipline.
• 3–5+ years of Quality Engineering experience within a regulated industry.
• Medical Device industry experience strongly preferred.
• Proven experience supporting the introduction and implementation of new technologies within a Medical Device manufacturing environment.
• Strong knowledge and hands‑on experience with:
• Process Validation
• Test Method Validation
• Equipment/Software Validation
• Quality Risk Management
• Statistical Analysis
• Root Cause Analysis and Corrective Actions
• Working knowledge of FDA QSR/GMP requirements applicable to Medical Devices.
• Strong understanding of ISO 13485 and ISO 9001 quality management systems.
• Experience working in cross‑functional project teams and supporting technology transfer or New Technology Introduction activities.
• Strong documentation, analytical, problem‑solving, and project management skills.
• Strong cross‑functional collaboration and teamwork
• Effective influencing and stakeholder‑management skills
• Project management capabilities
• Methodical and analytical approach to problem‑solving
• Flexible and adaptable
• Culturally aware and collaborative
• Ability to work effectively across technical and business functions
• Strong Quality generalist with hands‑on industry experience
• Ability to de‑escalate issues and facilitate constructive resolution