Quality Systems / Design Assurance Engineer

• Support and maintain medical quality systems in alignment with U.S. FDA expectations and applicable regulatory requirements.

• Develop, review, and manage design requirements, including:

• User Needs

• Stakeholder Needs

• Product Requirements
• Support design control activities throughout the product development process.

• Perform risk management activities in accordance with industry standards, including:

• Historical complaint analysis and trending

• Identification of hazards and hazardous situations

• Design Failure Mode and Effects Analysis (dFMEA)

• System-level risk assessments

• Development and maintenance of Risk Management Plans (RMP)

• Preparation and maintenance of Risk Management Reports (RMR)
• Collaborate with cross-functional teams to ensure design documentation is complete, accurate, and compliant with regulatory requirements.
• Support continuous improvement initiatives within the Quality Management System (QMS).

We are seeking a Quality Systems / Design Assurance Engineer to support medical device quality systems and product development activities in compliance with U.S. FDA regulations. The ideal candidate will have hands-on experience with design controls, quality management systems, and medical device risk management throughout the product development lifecycle., * Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.

• Experience working within a medical device Quality Management System (QMS) aligned with U.S. FDA regulations.
• Hands-on experience with design requirements, design controls, and risk management processes.

• Strong understanding of:

• Complaint trending and analysis

• Hazard identification and hazard analysis

• Risk documentation and risk assessments
• Excellent analytical, documentation, and problem-solving skills.
• Strong verbal and written communication skills with the ability to work effectively on cross-functional teams.

Preferred Qualifications

• Experience with medical device product development.
• Knowledge of FDA Design Controls and Quality System Regulation (21 CFR Part 820/QMSR).
• Experience applying ISO 14971 risk management principles.
• Experience preparing or maintaining dFMEA, Risk Management Plans (RMP), and Risk Management Reports (RMR).

Preferred Skills

• Medical Device Quality Management Systems (QMS)
• FDA Regulations (21 CFR Part 820/QMSR)
• Design Controls
• Requirements Management
• Risk Management
• ISO 14971
• dFMEA
• Hazard Analysis
• Complaint Handling and Trending
• System Risk Assessments
• Technical Documentation
• Cross-functional Collaboration

Pay: $81,489.98 - $98,138.48 per year

Education:

• Bachelor’s (Required)

Experience:

• medical device Quality Management System (QMS) : 3 years (Required)