Adeline Fourcot Email & Phone Number

Villawood

As a Quality Management & Compliance Specialist with leadership experience, I develop and maintain robust Quality Management Systems (QMS) in alignment with ISO 13485 standards, backed by extensive exposure to 21 CFR part 820 regulations. I lead internal and supplier audits, manage risk assessments for product development, and ensure the seamless integration of new products into our portfolio. My strong problem-solving and continuous improvement skills enable me to effectively oversee documentation processes, monitor key quality performance indicators (KPIs), and drive initiatives that enhance quality standards. I report outcomes to senior leadership, manage supplier relationships, oversee product releases, and provide training and guidance to team members, all while fostering a culture of quality excellence.

North Ryde, New South Wales, Australia

As Quality Assurance Professional, I leverage strong continuous improvement and problem-solving skills to provide quality input for new product introductions, product divestments, and acquisitions. I actively coach and mentor stakeholders across various functions, including Marketing, Sales, Supply Chain, and Operations. My role involves managing NCRs, CAPAs, Change Controls, and facilitating quality reviews for Biologic products. I ensure compliance with Johnson & Johnson standards, support global and local process improvement initiatives, and integrate these into the local QMS. Additionally, I lead internal and supplier audits, manage supplier relationships, and oversee the implementation and enhancement of Quality Management Systems. My achievements include successfully leading complex global audits and developing training programs for local stakeholders.Significant Achievements:• Successful achievements in a global and local process improvement initiatives and integrating localised strategies and developing the training for local stakeholder.• Achieved success through the successful completion as a Lead auditor (leading a team of 4 people across the Globe) to conduct a remote complex Biologics supplier audit conducted in different time zone.

As a Senior Quality Assurance Associate, I ensure compliance with ISO 13485:2016 and other regulatory standards for Class IIa medical devices, effectively integrating new requirements into the local QMS and aligning with corporate standards. As a leader, I mentor and coach the Quality Engineering function, lead internal audits, and oversee validation teams to ensure biocompatibility of products. My role includes organizing Management Reviews, CAPA Board meetings, and managing the document control system. I collaborate with internal stakeholders to resolve non-conformances, follow through on CAPAs, and exposed to risk assessments and MDR/Vigilance reporting. Additionally, I ensure compliance with Australian and EU medical device regulations and administer local training management systems, driving continuous improvement and maintaining high-quality standards across the business.

Macquarie Park, New South Wales, Australia

· Ensured in the day-to-day operations, the organization is compliant to the Quality Management System standards (ISO 9001/ISO 13485) and other applicable regulatory requirements in an effective and efficient manner for Class IIa MD.· Integrated the New ISO 13485:2016 requirements to the local QMS (Gap analysis) and align with the Corporate requirements.· Planning and conducting regular internal audits across the business in accordance with the guidelines of the relevant standards.· Reviewed and trended the complaints (managed by a Complaint Management System SalesForceDotCom (SFDC) to ensure the continuous improvement (using Problem Solving Group and 5S strategy) and enhance our processes.· Lead and created the Validation Master Plan of all the Operational activities (Risk assessment PFMEA, development of the Validation strategy).· Organized and lead the periodic Management Reviews and CAPA board meetings.· Managed, Collaborated and enhanced with internal stakeholders to follow through CAPAs to completion in a timely manner.· Coordinated and administered the document Management System, change control system and Quality records system.· Ensured compliance of documents to Corporate QA policies and incorporate into QMS· Compiled and supplied regular and accurate QMS reports and information relating as required by the QA/RA Manager or Management team.· Implemented the MDR/Vigilance reporting procedure and ensure compliance to regulatory requirements.· Experience in Australian Medical Device Regulation and EU regulations, ERP (Agile, SFDC)· Ensured compliance to local requirements (TGA) and external requirements (ISO13485), incorporate into QMS and ensure compliance across the business.· Supported as Quality on project.· Provided support to projects.· Managed Quality Control processes in Production and logistics Department.· Developed material for training purpose and competency assessment when required.

St Leonards, Australia

• Improve the process of the Environmental Monitoring of the Cleanroom (Review technical and performance specifications, quality levels, trending data, development of monitoring charts, scheduling tests, updating documentation and writing annual reports)• Coordinate Customer Complaints (evaluate and investigate issues, management of returned devices and finalizing and closing complaints).• Coordinate and perform the project packaging shelf life study to ensure compliance with Standards and the local procedures.• Create Competency questionnaires to assess employee training.• Update and implement local procedures to ensure compliance with relevant regulations, Standards and local practices.

Sydney, Australia

Raised my daughter and developed her education with different activitiesEnjoyed all the good time spent with her

France

• Established and implemented the project “Knapp Test” (visual inspection Qualification over 1 year)• Defined and created all the Quality standards useful to perform the Knapp Test : risks analysis, documentations, materials• Coordinated the creation of particulate defects set (supervised subcontractor)• Performed all work in accordance with the FDA, the Pharmaceutical regulations and the Quality Management System of Becton Dickinson• Created training materials for the “Knapp Test” project and carried out training of all employees involved in the Quality Assurance process• Expert of visual inspection process• Managed post implementation review to ensure prevention of similar issues encountered in the manufacture of devices and visual inspection processes• Updated and implemented local procedures to ensure compliance with the regulations, the international and the local procedures.• Ensured the corrective action plan (audit, routine process)• Performed the equipment’s validation

France

• Active work group leader (4 subordinates) and managed some projects• Established and implemented visual inspection project (over 3 years) essential to Quality Control of the end product (risk analysis, procedures, process, training) in accordance with the Quality Management Systems• Analyzed and created from scratch all required standard operating procedures for all GMP operations: manufacturing and packaging of clinical trials devices (risks analyses, protocol, batch record, processes)• Trained all the employees at the visual inspection process• Expert of semi-automatic inspection and responsible for creating and managing the “defects set”• Coordinated and planned the manufacturing and packaging of clinical trials devices in accordance with cGMP (American regulations) and BPF (French regulations)• Established and supervised order processing activities for clinical trials (documentation, needs analysis, process outlines, and equipment verification)• Filled, packaged and assured the reconciliation of medical devices for clinical studies• Participated at the manufacturing process of the medical devices with generic products (filling and visual inspection)

France

• Coordinated and planned the manufacturing and packaging of clinical trials devices in accordance with cGMP (American regulations) and BPF (French regulations)• Responsible for order fulfillment, preparing and packaging of medical devices for clinical studies at the clinical research center Alphamap, France • Filled, packaged and ensure the reconciliation of medical devices for clinical studies• Ensured the Quality control of all the manufacturing operations