Senior Design Quality Engineer

This role serves as the quality lead within product development, owning design controls, risk management, and regulatory compliance throughout the product lifecycle. You will work cross-functionally to ensure all products meet global quality standards while driving documentation, validation, and continuous improvement activities.

• Lead design quality and risk activities across product development.
• Ensure compliant, high-quality product delivery across teams., * Serve as the Design Controls Subject Matter Expert, ensuring proper execution of all design control phases
• Act as the quality lead on product development teams, ensuring compliance with internal procedures and global regulatory requirements
• Own and maintain Design History Files (DHF), ensuring completeness and accuracy throughout development phases
• Lead risk management activities, including authoring plans and reports and facilitating cross-functional risk assessments
• Ensure all applicable technical standards and design requirements are incorporated into new and modified products
• Review and approve Engineering Change Orders (ECOs) from external manufacturers and assess associated risk documentation
• Support development, review, and maintenance of quality procedures, documentation, and technical data forms
• Ensure adherence to Quality Management System (QMS) processes and documentation requirements
• Review validation protocols and reports to ensure GMP and regulatory compliance
• Lead investigations into non-conformances, customer complaints, and CAPAs, ensuring timely resolution
• Support internal audit activities and ongoing QMS maintenance and improvement efforts
• Provide training and guidance on quality systems, design controls, and engineering best practices
• Maintain knowledge of global standards and regulations, including ISO 13485, FDA 21 CFR Part 820/812, MDR, and MDSAP
• Collaborate cross-functionally with engineering, manufacturing, regulatory, and external partners

• Bachelor’s degree in Engineering (Electrical Engineering preferred)
• 5-10 years of experience in the medical device industry or regulated environment
• Strong experience in design controls, risk management, and quality or product development engineering
• Deep knowledge of global quality and regulatory standards (ISO 13485, FDA 21 CFR Part 820, MDSAP, MDR)
• Experience with medical instrumentation or complex technical products
• Strong technical writing and documentation skills
• Proven ability to work independently with minimal supervision
• Excellent analytical, problem-solving, and root cause investigation capabilities
• Strong communication and organizational skills with ability to influence cross-functional teams
• Proficiency with MS Office tools (Word, Excel) and quality documentation systems
• Experience in regulated industries such as medical devices, defense, or related highly controlled environments preferred

• Competitive salary with strong growth potential in a high-impact individual contributor role
• Comprehensive benefits package (medical, dental, vision, etc.)
• Opportunity to play a key role in product development and regulatory compliance for innovative medical technologies
• Exposure to cross-functional leadership and global regulatory environments
• Ability to drive quality excellence across engineering and product development teams

Our client is a medical device organization focused on developing and commercializing innovative technologies within a highly regulated environment. Operating under stringent global quality and regulatory standards, including ISO 13485 and FDA requirements, they emphasize strong collaboration between product development and quality teams to ensure safe, effective, and compliant products. Their culture promotes technical rigor, accountability, and continuous improvement across the product lifecycle.