Tabitha Gibbs Email & Phone Number

Amsterdam, Noord-Holland, Nl

The Innovation and Strategy organization for Philips focuses on key innovations and strategic direction to enable Philips continued growth in the Healthtech space. It includes the Chief Technology Office, Research organization, Intellectual Property and Standards, Mergers and Acquisitions, Internal Platform and component development and company sponsored start-up organizations. Responsible for ensuring Quality throughout the product life cycle, focused on early development and novel technologies.Responsible for coordinating multiple strategic initiatives and ensuring that Quality function is embedded appropriately in decisionsActs as subject matter expert for Quality in cross-functional teams, including representing the Quality function in the I&S Management TeamResponsible for talent development of Quality personnel to ensure appropriate level of competency to support product development and other quality initiatives Establishing and reporting quality metrics; driving quality improvement initiativesActing as Person Responsible for Regulatory Compliance (PRRC) and Management RepresentativeAccountable for site and product compliance with regulations for medical and non-medical devicesCreates and oversees execution of strategic plans for the convergence and certification of Quality SystemsManages multiple sites across the globe, including India, China and Europe.

Amsterdam, Noord-Holland, Nl

The Chief Technology Office houses initial research organizations as well as organizations which focus on creating common components for use in a variety of medical devices. Responsible for ensuring Quality throughout the initial research and development phase, including pre-clinical and clinical studies. Manages multiple sites across the globe, including India, China and Europe.Executes strategic plans for the convergence and certification of Quality SystemsEnsures early development is positioned for regulatory clearance and integration into to-be-launched productsPartners with regulatory and clinical teams to ensure successful clinical trialsDevelops and enacts strategic decisions to maximize re-use of common components from research and platform development teamsAll responsibilities listed below

Amsterdam, Noord-Holland, Nl

Ensures that regulatory strategies adequately support product development activities and result in the timely approval of new and revised products.Represent the business during any audit processes, internal or external. Drive compliance across all functions of the business and ensure preparedness for any audits. Take action on any audit findings, to reinforce compliance or remedial action on any unsatisfactory findings.Works with Corporate Quality Assurance and other quality assurance and regulatory leaders across the corporation to identify and implement best practices. Maintains productive working relationships with external regulatory bodies. Implements appropriate activities to ensure regulatory compliance and adherence effectiveness of the quality system such as: complaint handling, corrective and preventive action, and the internal audit program. Champions and implements process improvements to improve quality, compliance and provide guidance in compliant LEAN thinking.Monitors external changes to the regulatory environment to ensure the continued compliance of the quality system. Assesses new regulations for applicability to product line (e.g. EU MDR)Participates in customer sales interactions and on-boarding; provides validation and regulatory support.

Alpharetta, Ga, Us

Q&R site lead responsible for Q&R function and QMS at the siteResponsible for regulatory interactions at siteImplements, maintains, and enforces a compliant and effective QMS and harmonize it across the Business, ensures (local) process ownership for all activities within the scope of the QMSEnsures compliance to worldwide regulations/standards as required, guidelines and policies to all products and operations are consistent with those regulations/standardsActively educates and promotes the QMS to achieve a quality and regulatory compliance culture throughout the organization while effectively performing QMS and culture change managementEnsures quality monitoring activities are established and key metrics are reportedResponsible for the review and approval of finished products for and by the company in accordance with their approved specifications. Introduces and implements the quality processes and tools required to ensure product quality and customer satisfaction; includes Complaint Handling and CAPA Manages product recall activities to include recall policies and procedures for the company. Additionally, manage product complaint activities and processesServe as a resource to facilitate CAPA investigations including, root cause analysis and developing/implementing corrective action plans, ensuring relevant information is accurately documented and that actions are on trackRepresents the Supplier Quality function within the Q&R department

Amsterdam, Noord-Holland, Nl

Serves as organization representative in cross-organizational projects.Supports internal audit process and CAPA process for North America primarily, South America as neededRevises and implements internal audit and CAPA processesActs as Subject Matter Expert for Quality and Regulatory questionsManages staff of Q&R Specialists in USA and CanadaAdministrator for software tools used for audit and CAPA recordsLead Auditor for internal audits in United States and CanadaResponsible for ensuring CAPA team met corporate key performance indicators (KPIs) for CAPA and providing reports for management reviewProvides on-going training to employeesReviews Installation Documentation as necessary for regulatory complianceOrganizes and Leads Team and Cross-Functional meetingsOrganizes and Leads CAPA Review Board meetings

Amsterdam, Noord-Holland, Nl

Serves as organization representative in cross-organizational projects.Supports internal audit process and CAPA process for North America primarily, South America as neededRevises and implements internal audit and CAPA processesActs as Subject Matter Expert for Quality and Regulatory questionsManages staff of CAPA Facilitators in USA and provided support for Facilitators in Canada and Puerto RicoAdministrator for software tools used for audit and CAPA recordsLead Auditor for internal audits in United States and CanadaResponsible for ensuring CAPA team met corporate key performance indicators (KPIs) for CAPA and providing reports for management reviewProvides on-going training to employeesManages CAPA SharePoint siteReviews Installation Documentation as necessary for regulatory complianceOrganizes and Leads Team and Cross-Functional meetingsOrganizes and Leads CAPA Review Board meetings

Amsterdam, Noord-Holland, Nl

Responsible for facilitating the completion of CAPAs from start to finish, including- Identifying and fully defining a problem- Root Cause analysis- Identifying Corrective Actions- Implementation and effectiveness monitoring of Corrective ActionsResponsible for maintaining the CAPA record using TrackWise software and assisting others in it's use

Waltham, Ma, Us

Regularly performs monthly Quality and Safety auditsOrganizes and leads annual comprehensive Quality System auditConducts employee training and maintains recordsAssists in regulatory audits and inspectionsAssists in compiling CE Mark technical files for European submissionPerforms validation for new equipment or processesPerforms internal calibrations for equipmentResponsible for releasing raw materials to inventoryInspects finish goods prior to releaseResponsible for Document Control practicesResponsible for writing and editing SOPs and DMRsManages facility complaint handlingConducts vendor qualificationsManages all aspects of CAPA systemAssists in composing customer and regulatory notifications for recallsCompiles documentation for and monitors status of recalls

Waltham, Ma, Us

Regularly performs monthly preventive and corrective maintenance checksParticipates in monthly Quality and Safety auditsCertified internal auditor for ISO 13485Participates as auditor in semi-annual auditsAssisted in compiling CE Mark technical files for European submissionParticipated in ISO 13485 re-certification auditDeveloped customized Access database to track CAPA and Training records thus reducing data entry time substantiallyPerformed Software validation for developed databasesExperienced in inspecting raw materials and finished goods for releaseKnowledgeable regarding Document Control practices

Waltham, Ma, Us

Responsible for producing Device History Records from Master RecordsProduced the chemical substrates for in vitro diagnostic devicesResponsible for recording inventory changes in SAP inventory softwareAssisted in harvesting bacteria from blood plates for production useRequired to use common laboratory equipment Responsible for preparing test substrates for R&D evaluation

Prepared micro-liter solutions of crown ethers and saltsUsed NMR spectrometry to analyze how ions bind to crown ethersPrepared inorganic solutions for analysisUsed UV spectrometer to analyze inorganic solutions

Masters Of Pharmacy, Regulatory Affairs

Bachelor Of Science (B.S.), Chemistry

Bs, Chemistry