Leading the development of value adding and pragmatic medical device 13485 QMS systems.Creating innovative knowledge sharing content on a variety of platforms and media types to enhance capability and skills sets.Exploding through limitations and challenges to achieve extraordinary things.

Responsible for providing quality management, guidance, and oversight from a regulatory/quality compliance perspective for all medical devices manufactured by (or on behalf of) Jazz. This includes ensuring Jazz devices are compliant with EU Regulation 2017/745 on Medical Devices (MDR) and EU Regulation 2017/746 on In-Vitro Diagnostic Devices (IVDR); guidance issued by FDA's Center for Devices and Radiological Health (CDRH) including 21CFR Part 807, and UK MHRA Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) plus other global regulations for devices where appropriate. The role is also responsible for supporting the registration of Drug-Device combination products and ensuring they are compliant with the above regulations where applicable. Act as (or supervise) the person responsible for regulatory compliance to ensure the conformity of Jazz devices is appropriately reviewed and approved, in accordance with the quality management system and applicable specifications before a device is released. Develop a ‘Centre of Excellence’ for Medical Device quality at Jazz.

Leading quality excellence in drug discovery and API development, through integration of quality by design technologies in product development lifecycles.Quality Assurance leadership of medical device design and development projects (digital and mechanical device development work streams).Creation and Management of Technical Documentation/DHF for bespoke medical device products.Leading the development and enhancement of the GW QMS incorporating 13485:2016, 93/42/EEC MDD, 2017/745 MDR and 21 CFR Subpart H - Medical Devices Part 820 Quality System Regulation.

Focused management of medical device and cosmetic product quality system, in accordance with ISO13485 and ISO22716 standards.Proactive approach to QMS transformation, continuous improvement and optimization to adjust to changing regulatory landscapes. Brexit transition managementCSV and Validation lifecycle managementQMS developmentLine managementBusiness quality system fucussedLean Sigma Black Belt

Management and improvement of quality systems processes, TQM and CSV for the manufacture of medical device and cosmetic products.Successful management of ISO13485:2016 gap analysis and RFT transition.ISO22716 ComplianceTeam managementCoaching and DevelopmentContinuous ImprovementDigital Transformations to paperless qualityDisciplinary and Grievance management

Responsible for the development of a commercially aligned, formulation development QMS utilising GMP, GLP, GDP principles to deliver high quality product development projects and successful transfers to commercial manufacturing functions.Accountability for day to day quality management within a contract manufacturing and development organisation.Balancing commercial product supply and development projects for high potency drug formulations.Stakeholder in the evolution of a multidiscipline drug formulation facility.Facility commissioning, qualification and validation programs.

Quality system development and optimisation, design control governance for medical device design and development. Continuous improvement of quality system processes and business processes. Accountability and ownership of quality processes. Supplier management, internal and external auditing, training and coaching, human factors engineering process design, risk management, client facing device design.ISO 13485, 14791, 9001 quality system process development, 62366 Usability Engineering

Quality system optimisation and rationalisation, product launch and PAI readiness management.Project management through PMO style business model and stage gate approach.NDA preparation project management for small volume , high potency API submissions.Certified LeanSigma Black belt with proven capability of leading large scale global continuous improvement projects.

Responsible for leading projects in quality systems simplification, manufacturing process harmonisation, product transfers and global collaborations. Accredited lean sigma green belt and training blackbelt , utilising lean sigma concepts and prince2 principles for project management.

Responsible for facilitating investigations into process errors, nonconformancies and deviations. Utilising root cause analysis tools and lean sign concepts led improvement projects to improve CAPA processes and standards of investigations

QC laboratory technician, analyst and senior analyst.