Lead Design Quality Engineer

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

Our Client is seeking a Lead Design Quality Engineer to join their Quality team in Madison, WI. This individual will take ownership of design-control quality engineering for a medical device portfolio, partnering closely with R&D and Regulatory Affairs throughout new product development and sustaining design changes.

This role will have a strong focus on design controls, new product development, design changes, risk management, and computer system validation (CSV). The Lead Design Quality Engineer will ensure design inputs, outputs, verification, validation, and risk management activities meet applicable FDA, ISO 13485, ISO 14971, and EU MDR requirements.

Key Responsibilities

• Own the Quality Assurance role throughout design control activities, supporting both New Product Development (NPD) and sustaining design changes.
• Manage and maintain the Design and Development File (DDF), which fulfills the traditional Design History File (DHF) role.
• Maintain the Risk Management Plan, Risk Management Report, and Risk Management File.
• Facilitate design risk management activities, including FMEA and risk analysis, in accordance with ISO 14971.
• Participate on the Design Review Team and ensure design deliverables are complete, verified, and compliant with applicable quality and regulatory requirements before progressing through phase gates.
• Ensure design verification and validation (V&V) testing is performed according to approved plans and results are appropriately documented.
• Review and approve engineering change orders impacting device design.
• Identify regulatory requirements and applicable standards across outsourced design activities.
• Partner closely with R&D, Regulatory Affairs, and Manufacturing Engineering on design transfer and design change control.
• Support Computer System Validation (CSV) activities for systems supporting design and quality processes.
• Support internal and external audits related to design controls, including hosting regulatory and Notified Body auditors as needed.

Required Qualifications

• Bachelor's degree in Engineering or a related technical field, or an equivalent combination of education and experience.
• 5+ years of Quality Engineering experience within a medical device manufacturing environment, with a strong focus on design controls and/or new product development.
• Working knowledge of ISO 13485, 21 CFR Part 820, and ISO 14971.
• Strong understanding of medical device design controls, risk management, and verification and validation processes.
• Demonstrated experience supporting internal and/or external quality audits.
• Ability to work cross-functionally with R&D, Regulatory Affairs, Manufacturing Engineering, and other technical teams.
• Proficiency with Microsoft Office or similar business applications.

Preferred Qualifications

• ASQ certification, such as CQE, CRE, or equivalent.
• Experience hosting or supporting Notified Body, Registrar, or FDA audits/inspections.
• Experience working with electronic Quality Management Systems (eQMS).
• Experience with ComplianceQuest is a plus.
• Previous Computer System Validation (CSV) or software validation experience.

This is an onsite position in Madison, Wisconsin, working within an office and light manufacturing/laboratory environment. The position may require extended periods of sitting or standing, regular computer use, and occasional lifting of up to 25 lbs.