Senior Design Quality Engineer - Medical Device - Medford, NJ

We are seeking an experienced Senior Design Quality Engineer to serve as the quality lead for new product development and sustaining engineering initiatives within a highly regulated medical device environment. This role will drive design controls, risk management, Design History File compliance, and cross-functional quality activities from concept through commercialization.

• Lead quality strategy for innovative Class III medical technologies
• Own design controls and risk management in a growing organisation, * Act as the Design Controls subject matter expert, ensuring compliance throughout all phases of product development.
• Partner closely with Product Development teams to drive quality activities for new product introductions and design changes.
• Lead risk management activities, including risk assessments, risk management plans, and risk management reports.
• Own and maintain risk documentation supporting product and process development activities.
• Manage Design History File reviews and verification’s throughout the design life cycle.
• Review and approve engineering change documentation while assessing associated product risks.
• Support the development, revision, and continuous improvement of quality system procedures and documentation.
• Review validation protocols and reports to ensure compliance with regulatory and GMP requirements.
• Conduct internal audits and support Quality Management System effectiveness.
• Lead investigations related to nonconformances, customer complaints, and corrective actions.
• Drive timely resolution of quality issues through root cause analysis and corrective action implementation.
• Provide quality system training and mentorship across the organization.
• Support compliance with ISO 13485, FDA regulations, MDSAP, MDR, and other global quality standards.
• Develop technical procedures, failure analysis documentation, and quality engineering reports.

• Bachelor’s degree in Electrical Engineering; advanced degree preferred.
• 10+ years of experience within medical devices or another highly regulated industry.
• Strong experience in Design Controls and Product Development support.
• Expertise with Risk Management methodologies, including authoring and facilitating risk assessments.
• Thorough understanding of ISO 13485, FDA 21 CFR Part 820, MDSAP, MDR, and related regulations.
• Experience supporting Design History Files, validation activities, and quality system compliance.
• Ability to work independently while effectively collaborating across cross-functional teams.
• Excellent technical writing, communication, project management, and problem-solving skills.
• Background in medical instrumentation preferred.
• Experience within medical devices, defense, military, or similarly regulated industries highly valued.

• Direct impact on breakthrough medical technologies that improve patient’s lives.
• Highly visible role partnering with engineering and executive leadership.
• Opportunity to lead quality strategy across the entire product development life cycle.
• Exposure to advanced medical device technologies in a complex regulatory environment.
• Strong career growth potential within an innovative and expanding organization.

Our client is an innovative medical technology company focused on developing life-changing therapies that improve patient outcomes worldwide. They combine cutting-edge engineering with a strong quality culture, offering employees the opportunity to make a meaningful impact while working alongside highly experienced industry leaders.