Medical Device Quality Assurance Engineer — PV/PPQ & Risk

Fives DyAG Corp.; Boston (MA); On-site; USD 110,000 - 140,000; Full time

Job summary

Fives DyAG Corp. seeks a Quality Assurance Engineer for medical devices to support quality activities across development and manufacturing lifecycles. You will apply rigorous processes to ensure compliance and product reliability.

You will lead PV/PPQ, DFMEA/PFMEA, and design controls while performing risk management, product testing, and cross-functional collaboration with Engineering, Regulatory, and Operations teams.

Qualifications

• Bachelor's degree in engineering, Science, or another relevant technical discipline.
• 5+ years of experience in the medical device industry, preferably in Quality Engineering or Quality Assurance.
• Hands-on experience with Process Verification and Validation.
• Experience with risk management, product testing, and quality problem-solving.

Responsibilities

• Conduct and support PV/PPQ activities per procedures and regulatory requirements.
• Develop, review, and maintain DFMEA and PFMEA documentation.
• Support Design Control activities throughout the development lifecycle.
• Perform product and process risk assessments and document results.
• Support testing, verification, and validation activities with proper records.
• Interpret blueprints, GD&T, and technical specifications.
• Participate in NPD and provide QA support from development to production.
• Support CAPA, nonconforming material, deviations, and corrective actions.
• Investigate quality issues using root-cause analysis and problem-solving.
• Ensure compliance with medical device quality and regulatory standards.
• Collaborate across Manufacturing, R&D, Regulatory, and Operations.
• Engage in continuous improvement using Lean/Six Sigma methodologies.
• Provide QA input to leadership on quality initiatives and programs.
• Manage multiple projects with timelines and quality objectives.

Skills

Process Verification

Process Validation

DFMEA

PFMEA

Design Controls

Risk Management

Root Cause Analysis

Lean Six Sigma

Quality Testing

Regulatory Compliance

Education

Bachelor's degree in engineering

5+ years medical device quality experience

Job description

Fives DyAG Corp. seeks a Quality Assurance Engineer for medical devices to support quality activities across development and manufacturing lifecycles. You will apply rigorous processes to ensure compliance and product reliability.

You will lead PV/PPQ, DFMEA/PFMEA, and design controls while performing risk management, product testing, and cross-functional collaboration with Engineering, Regulatory, and Operations teams.