Spearhead the development, implementation, and continuous improvement of the QMS.Ensuring alignment of quality processes with company goals and regulatory requirements.Lead the regulatory affairs activities such as file preparation and submissions to ensure compliance with relevant industry standards, regulations, and guidelines.Collaboration and interface with regulatory agencies to support product registrations and approvals.Driving initiatives to embed quality into every aspect of product development, manufacturing, and deliveryDevelop and implement a robust risk management program to identify, assess, and mitigate potential risks associated with products and processes.Working closely with product development teams to integrate risk management principles into the design and development phases.Collaborate closely with cross-functional teams, providing quality expertise and guidance from product conception to commercialisation.Working with R&I, Product Development, Product Bioprocessing and Commercial and teams to integrate quality considerations into product design and development.

At Compliance Solutions, I am an integral part of a dynamic team dedicated to providing exceptional Quality, Regulatory, and Clinical consulting services to a wide array of medical device, in vitro diagnostic, and life science companies operating across various regions. Our mission was to support these clients in navigating the intricate landscape of regulatory compliance, including ISO standards, EU MDR, EU IVDR, and more. In my role, I held multifaceted responsibilities that were pivotal in ensuring our clients' success and compliance with stringent regulations.My contributions encompassed offering expert guidance to clients, helping them meet the rigorous regulatory requirements set by authorities like the MHRA, FDA, MDR, IVDR, and Notified Bodies. Utilizing a risk-based approach, I tailored solutions precisely to our clients' Quality and Regulatory needs, which included the design, implementation, and meticulous maintenance of Quality Management Systems aligned with relevant standards. Additionally, I adeptly prepared Technical files, design dossiers, and 510k submissions, facilitating the smooth regulatory approval process. My role also extended to conducting internal audits and hosting audits by Notified Bodies, ensuring compliance and fostering continuous improvement. Furthermore, I provided essential support for Corrective and Preventive Actions (CAPA), Non-Conformances (NCs), and complaint resolution, underscoring my commitment to maintaining the highest standards of quality and regulatory compliance in the healthcare industry.

During my 18-month contact at Ultimate Healthcare, a leading supplier to Care Home Distributors, the NHS, and Social Services, I played a pivotal role in our transition from the Medical Device Directive (MDD) to the more rigorous Medical Device Regulation (MDR). As the Interim QA/RA Manager and Complaints Specialist, my responsibilities were diverse and comprehensive.I managed feedback, ensuring prompt resolution and a commitment to continuous improvement. Through vigilant data analysis, I closely monitored feedback trends, adverse events, and reports related to Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF), aligning decisions with data-driven insights. My role extended to assessing risk assessments, fortifying product safety as needed. I also led non-conformance investigations, Corrective and Preventive Actions (CAPA), and deviations, reinforcing our dedication to quality.I provided support for managing external and internal audit programs, conducting audits in compliance with regulations. Supplier evaluation, creating & agreeing supplier quality agreements, adapting the Quality Management System (QMS) to MDR, and ensuring regulatory compliance were integral parts of my role. Managing change controls for product modifications was critical, and I created technical files for various products, addressing sections like device descriptions, specifications, labeling, design, manufacturing, and risk management. My role included reviewing and amending product risk assessments to align with MDR Annex I, ISO standards, EN 60601, and REACH standards. Finally, I oversaw the review of Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) for class IIa devices, ensuring compliance with regulatory requirements.

During my time as QA Systems officer at Keeler Ltd, a prominent manufacturer and distributor of ophthalmic medical devices, I played a pivotal role in fortifying and enhancing our Quality Management System (QMS). This involved aligning our operations with stringent standards such as ISO13485, CFR 820.2, MDSAP, and MDR regulations. My responsibilities were multifaceted, including spearheading the development of Quality and Operational Quality functions within our QMS. Collaborating closely with area managers, I ensured that our processes adhered to industry best practices. Additionally, I led a dedicated team of eight professionals responsible for internal and supplier quality audits, maintaining the highest standards of quality throughout our operations.Furthermore, I performed and oversaw critical audits, including Unannounced and Notifying Bodies Audits, with the successful completion of an MDSAP audit in September 2020. I played a key role in supplier management, approving suppliers and establishing distribution Quality agreements for MDSAP, fostering strong partnerships with key stakeholders. Additionally, I streamlined customer feedback and complaint procedures, improving overall customer satisfaction. My collaboration with various departments, including Design, Project Management, Marketing, Sales, Operations, and the Managing Director, ensured compliance with current standards for both new products and modifications to existing ones. I also contributed to the successful implementation of the Medical Device Regulation (MDR) by providing crucial QA assistance to Regulatory Affairs (RA) to ensure adherence to regulatory requirements. Finally, I enhanced training efficiency by developing an electronic training matrix for Standard Operating Procedures (SOPs) and work instructions, facilitating the efficient dissemination of essential knowledge throughout the organization.

I held a pivotal role focused on enhancing operational quality functions and overseeing critical projects tied to the United Kingdom's CASD program. In this capacity, I ensured meticulous attention to detail by reviewing and overseeing the completion of essential documents such as Route-cards, non-conformities, concessions, and work permits. Furthermore, I played a central role in managing key performance indicators (KPIs) for Corrective and Preventive Actions (CAPA) and Problem Reports (PRs), taking the lead in conducting Root Cause Analyses for various projects. My dedication extended to resolving non-conformances (NCs) by closely collaborating with stakeholders and providing essential support to Manufacturing Engineers. Throughout the program and project lifecycle, I prioritized quality representation, ensuring that quality considerations remained paramount in all decision-making processes. My commitment to delivering high-quality results included providing technical guidance and unwavering customer support, enabling the achievement of deliverables and targets within established parameters. I also maintained control over inspection, calibration, reporting, and related processes to uphold the highest quality standards. Additionally, I contributed significantly to capability development within the organization by delivering technical assessments using appropriate methodologies. In my role as chairperson for Corrective and Preventive Action (CAPA) and Non-Conformance (NC) review boards, I led discussions and decisions to drive continuous improvement initiatives.

I managed a wide array of medical and clinical devices, particularly focusing on upper limb, lower limb, and pelvis implants. My responsibilities included scrutiny of Device History Records (DHR) and Device Master Records (DMR) for custom-made implants, guaranteeing strict compliance and traceability throughout their lifecycle, from design and manufacturing to inspection, packaging, cleaning, labeling, and addressing any non-conformances, Corrective and Preventive Actions (CAPAs), & change controls. I also played a vital role in reviewing and approving documentation and products slated for supplier dispatch, consistently upholding excellence standards for custom implants. I maintained a robust set of metrics and Key Performance Indicators (KPIs) to monitor right-first-time performance and non-conformances, specifically related to custom devices' DHR & DMR.Documented and escalated non-conformances, efficiently transitioning them into Non-Conformance Material Reports , Supplier Corrective Action Requests, change controls, or CAPAs as required by the situation's demands. My expertise in the TrackWise NC system facilitated active collaboration with Operations, Product Quality, and Supplier Quality teams to initiate, investigate, and approve NCs for closure, often leading NC meetings to ensure swift resolution. Root cause analyses for Corrective and Preventive Actions also fell under my purview, utilising analytical tools like 8D, Fishbone diagrams, and the 5 Whys technique. My role extended to reviewing and endorsing the return of finished goods, instruments, and trial kits, ensuring all products met the highest quality standards. Preparing and reviewing technical documentation for clinical use products, guaranteeing adherence to rigorous standards, and maintained open lines of communication and collaboration with relevant departments to convey product status, reasons behind holds, quarantines, rejections, rework, scrap, returns to suppliers, and key milestones.

In my role at Microtest Dx, I collaborated closely with the acting QA/RA manager to implement, manage, and enhance the company's quality management systems. These efforts were aligned with stringent standards such as ISO 13485:2012, ISO 9001:2008, MEDDEV 2.12-1, 98/97/EC, and 93/42/EEC, with a primary focus on a groundbreaking fully-automated in vitro diagnostic (IVD) Class I medical device designed to test 26 allergens within a single patient sample.My responsibilities included creating and maintaining precise quality system procedures, expertly preparing regulatory submissions, and providing support for recertification initiatives. I also planned and executed supplier reviews and internal audits to ensure compliance. Additionally, I managed non-conformances, Corrective and Preventive Actions (CAPA), customer complaints, and change controls, initiating, investigating, completing, and meticulously documenting these critical processes. I contributed to the product release process by reviewing batch records and played a key role in delivering comprehensive quality-related training, ensuring compliance with the training plan. I also created and implemented procedures for Post Market Surveillance, Unannounced Audits, Customer Complaints, and Product Recall, all in perfect alignment with the rigorous standards set forth by ISO 13485. My dedication to maintaining exhaustive training records for all staff and fostering site-wide awareness and education on ISO 13485, GMP, and GDP contributed to our commitment to excellence in MDD and IVD medical device endeavors.

In my role at Thermo Fisher Scientific as a QA Officer/Document Controller, I ensured the integrity of the quality management systems that encompassed a diverse range of medical products, including Class I-IV IVDs, microbiological, and pharmaceutical items. Striving for excellence and compliance with strict regulatory standards, such as 21 FDA CFR 820, ISO 13485:2003, and ISO 9001:2008, was central to the mission.My responsibilities were extensive and included efficient communication facilitation to ensure seamless business processes. I managed the document control system on Mastercontrol and handled Quality Notifications (QNs) within SAP. Addressing customer inquiries and conducting surveys were also part of my role. I oversaw change control functions, reviewed and endorsed Corrective and Preventive Actions (CAPAs), and managed rework processes. Additionally, I conducted a variety of quality audits, both internal and external, ensuring comprehensive planning, execution, and follow-up. My role involved conducting thorough quality-based investigations, implementing corrective actions promptly, and maintaining detailed records and reports. Collaborating with internal and external stakeholders, providing expert guidance following audits, and delivering statistical reports on QA investigations and audits were also critical aspects of my work.