Tanya Lily M.

- Creation, maintenance, certification (MDSAP, ISO 13485, EU MDR) and continuous improvement of SeeTreat QMS - Supplier quality management - Management end execution of internal auditing - Host and coordination of external auditing e.g. European notified body - Change control process owner and lead - Document control management - Software owner of eQMS platform (Scilife) - CAPA lead - Preparation of Management Reviews (including analysis of data for Quality Objective and KPI metrics) - Inputs and review of product, system and subsystem requirements (design inputs) through to verification and validation of design outputs - Training creation, delivery and management - Development of post-market surveillance system including complaints handling and adverse event reporting - Support of Technical File submissions and regulatory affairs

- Oversight for the development and maintenance of quality programs, systems and procedures that ensure compliance with policies, and ensuring performance and quality of services conform to established internal and external standards and guidelines - Providing expertise and guidance in interpreting policies, regulatory and governmental regulations, along with internal regulations to assure compliance - Working directly with operating entities to provide process analyses oversight to enforce requirements and meet regulations - Supporting CAPAs and Audits as required - Preparing reports and necessary documentation and presenting to applicable stakeholders, both internal and external - Ensuring quality assurance programs and policies are maintained and improved regularly - Facilitating uniform, practical standards and ways of work internally - Reviewing and support of the validation of software used for quality processes

- Change Control Coordinator, facilitating change review board and Change Management process improvement - Design Quality Lead for new technology program, currently in early product development phase - Support for CAPAs with systemic quality issues as the root cause - Conducting internal audits in Lead Auditor role

- Supporting CT and CT subsystem product development programs (new and sustaining), leading proactive design assurance activities facilitating the development and release of high quality products. - Ensuring compliance to standards, regulation and internal processes - Providing guidance and support during investigation and resolution of product quality or compliance issues - Knowledge of standards, regulations, investigative/root cause processes, and procedures supporting compliance to industry and Philips product quality standards and requirements. - Providing technical expertise in the area of design assurance to Engineering, Operations, Customer Service, Field Service personnel and other business partners. - Guiding, coaching and training on investigative methods, risk mitigation techniques, and general product safety.

• Member of product development team responsible for supporting activities required to ensure quality of the design through compliance with design controls • Support establishment and maintenance of design and development plans • Work with engineering, clinical, marketing, regulatory, and other business partners to assure appropriate quality requirements are defined for the specific device application and target patient population • Recommend/promote testing methodologies and approaches required to confirm that the design output meets the design input • Participate in reviews of clinical relevant test methods, design verification test plans and results, and validation test plans and results • Work with R&D and manufacturing engineering to translate design requirements into manufacturing requirements ensuring device master record is complete and providing guidance to R&D, manufacturing and product quality engineering for development of manufacturing test/evaluation methods and process validation • Risk management activities and essential requirements analysis • Support compliance assessments of the DHF and other program files to ensure quality and regulatory requirements are achieved • Participate in reviews related to design, risk analysis and investigations, validation, defect classification and documentation • Responsible for ensuring defects, design changes and document changes are processed compliantly • Support post market surveillance, audit group, and other business partners in post-market activities • Work in a cross-functional, collaborative, team-based environment; work with multiple sites in various locations, time zones, and countries • Resource for problem investigations to guide root cause analysis and corrective action development

- Quality Management System Maintenance (ISO13485) including: • Document Review • Document Control • Traceability control • Equipment calibration records • Quality requirements for purchase orders • Product release and COCs • Training records • CAPAs • Non-conforming Material Reports • Supplier quality and auditing • Animal Trial Administration • ISO14001 (Environmental Management System) steering committee member

Responsible for the management of Regulatory Affairs and establishment and maintenance of Biovo's Quality Managament System resulting in CE and FDA approval of medical devices • Document control and traceability • Quality Assurance documentation and training • Participation in design reviews • Leading risk management process • MRBs, CAPAs, root cause analyses • Writing manufacturing documentation such as SOPs, work instructions and job travellers

• Drafting patent applications, patent research and investigation, reporting to foreign clients.

• Validation protocol including installation, operational and performance qualification for demoulding robot and automatic bagging machinery; documentation, including design protocols, and plant manuals; design and validation of anti-asphyxiation valve test rig for FDA approval for ResMed (sleep apnoea devices) • Preliminary detail design of major offshore coal briquetting plant for Binderless (Coal) Briquetting Company using AutoCad • Product analysis of trains as part of a major bid for public transport State contract for United Group Rail • Major crane rail inspection including strain gauging, non-destructive testing and visual inspection for Comalco Aluminium Smelter, Boyne Island Queensland

• Construction, CAD modelling and magnet testing of a new MRI machine prototype. Research for materials sourcing.