Medical Device Quality Assurance Engineer — PV/PPQ & Risk

Katalyst-Healthcares-; 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

Job Summary
We are seeking an experienced Quality Assurance Engineer – Medical Devices to support quality engineering activities throughout the product development and manufacturing lifecycle. The ideal candidate will have strong experience in medical device quality, process verification and validation, Design/Process FMEA, Design Controls, risk management, and product testing.
Roles and Responsibilities

• Conduct and support Process Verification and Process Validation (PV/PPQ) activities in accordance with established procedures and regulatory requirements.
• Develop, review, and maintain Design FMEA (DFMEA) and Process FMEA (PFMEA) documentation.
• Support Design Control activities throughout the product development lifecycle.
• Perform product and process risk management and risk assessments.
• Support product testing, verification, and validation activities and ensure appropriate documentation is completed.
• Interpret engineering blueprints, drawings, GD&T, and technical specifications.
• Participate in New Product Development (NPD) activities and provide quality engineering support from development through production implementation.
• Support CAPA, nonconforming material, deviation, and corrective/preventive action processes.
• Investigate quality issues using structured root-cause analysis and problem-solving methodologies.
• Support compliance with applicable medical device quality and regulatory requirements.
• Collaborate with manufacturing and onsite teams to ensure successful implementation of validated processes and quality requirements.
• Work cross-functionally with Engineering, Manufacturing, R&D, Regulatory, Operations, and other stakeholders to resolve quality issues.
• Participate in continuous improvement initiatives using Lean, Six Sigma, and other quality improvement methodologies.
• Provide quality input and technical support to senior leadership on quality initiatives and improvement programs.
• Manage multiple projects and priorities while meeting established timelines and quality objectives.
• Prepare, review, and maintain quality documentation, reports, and technical records.

Education and Experience

• 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.