Lead Design Quality Engineer - Medical Devices (Onsite)

Medasource; Madison (WI); On-site; USD 110,000 - 160,000; Full time

Job summary

Medasource seeks a Lead Design Quality Engineer in Madison, WI to own design-control quality engineering for a medical device portfolio, partnering with R&D and Regulatory Affairs throughout development and sustaining design changes.

The role focuses on design controls, risk management, and CSV, ensuring FDA/ISO compliance across inputs, outputs, V&V, and change control. Onsite in Madison, collaboration across functions drives product quality.

Qualifications

• Bachelor's degree in Engineering or related field or equivalent experience.
• 5+ years of Quality Engineering in a medical device manufacturing environment.
• Working knowledge of ISO 13485, 21 CFR Part 820, ISO 14971.
• Experience supporting internal/external audits.
• Ability to collaborate cross-functionally with R&D, Regulatory Affairs, and Manufacturing.

Responsibilities

• Own the Quality Assurance role throughout design control activities.
• Manage and maintain the Design and Development File (DDF) and DHF role.
• Maintain the Risk Management Plan, Risk Management Report, and Risk Management File.
• Facilitate design risk management activities, including FMEA and risk analysis.
• Participate on the Design Review Team and ensure design deliverables meet requirements.
• Ensure design verification and validation testing per approved plans and documentation.
• Review and approve engineering change orders impacting device design.
• Identify regulatory requirements across outsourced design activities.
• Partner with R&D, Regulatory Affairs, and Manufacturing Engineering on design transfer and changes.
• Support CSV activities for systems supporting design and quality processes.
• Support internal and external audits related to design controls.

Skills

Quality Engineering

Design Controls

Regulatory Affairs

FMEA

Risk Management

Cross-functional Collaboration

V&V

Audits

Education

Bachelor's degree in Engineering or related field

Tools

Microsoft Office

Job description

Medasource seeks a Lead Design Quality Engineer in Madison, WI to own design-control quality engineering for a medical device portfolio, partnering with R&D and Regulatory Affairs throughout development and sustaining design changes.

The role focuses on design controls, risk management, and CSV, ensuring FDA/ISO compliance across inputs, outputs, V&V, and change control. Onsite in Madison, collaboration across functions drives product quality.