Senior Consultant for the medical products industry.Recent consulting engagements have included the following: * Expert work within an R&D team developing a novel stem cell therapy. * Introducing Design Controls policy and procedures at a development-stage firm. * Developing product lifecycle management processes, through product discontinuation and retirement, at a large device company. * Working with multiple sites of a major device firm in the development and deployment of structured CAPA investigation and root cause identification processes and templates. * Facilitation and support of cross-functional investigation teams at a firm marketing combination products. * Development and introduction of a new approach to portfolio prioritization, working with senior management and PMO at a major device / pharma firm.Extensive experience with medical product quality systems. Specific expertise in operational and technical elements of quality systems development, deployment, and management. Hands-on experience with CAPA, production and process controls, design control, design transfer, change control, risk management, project management. Leadership experience with manufacturing and supplier transfers, CAPA systems and remediation, facilitation of structured technical investigation and problem-solving, independent technical review. Additional experience with design for X, quality system due diligence, technology assessment and due diligence, technology strategies and product lifecycle roadmaps.
Listed skills include Medical Devices, Capa, R&D, Design For Manufacturing, and 38 others.