Richard McQueen

Senior Design Quality Assurance Engineer @Mallinckrodt Pharmaceuticals

Dublin, IE

Mallinckrodt is a worldwide designer & manufacturer of innovative medical products. Key activities include;• Support new product design and development, design transfer, design validation & design review.• Design control compliance ensuring consistent, workable and compliant planning, development (inputs, outputs and review), testing (verification, validation and review), and change management• Regulatory compliance: ensuring product development (including software) and maintenance in accordance with FDA QSR\'s (21 CFR Part 820), ISO 13485 etc)• Ownership of design risk management activities, assuring appropriate and consistent risk management tool use i.e. FMEA, FTA, etc. for all programs and projects, compliant with ISO/EN 14971)• Interact with other functions such as Global Design Engineering (GDE), Manufacturing, Regulatory, Product Monitoring, Clinical and Operations as necessary

Paisley University

Diploma in Higher Education, Manufacturing Technology; Production Engineering