Aidan Casey Email & Phone Number

London, Gb

Abbott Park, Illinois, Us

Multi-site (55) responsibility for supporting the Abbott Laboratories in-country commercial affiliate compliance and Quality System programs across the globe. The core responsibilities of this role include: Lead Inspection Readiness of all in-country commercial affiliates, consisting of conducting pre-inspection audits, on-site inspection support, as well as post-inspection activities. Develop, implement, and maintain a robust QMS in compliance with international regulatory requirements, including multi-divisional harmonization of existing quality systems. On-market distribution controls, including internal and 3rd party logistics warehousesQuality System consulting relating to Investigations, CAPA, Change Management, Training, Document Management, Management Review/KPI measurements and Supplier Quality Conduct internal and supplier audits

Abbott Park, Illinois, Us

Multi-site responsibility for directing the Abbott Laboratories Diagnostic division compliance and audit programs across 8 manufacturing (Instrument and Biologics) sites located in USA and Europe. The core responsibilities of this role include FDA inspection readiness, internal consulting and training services, third party risk mitigation, project management of consent decree remediation efforts, and the harmonization of overall quality system compliance programs Manage and oversee the global internal audit program ensuring compliance with local, regional and international regulations Responsibility for directing the Abbott Laboratories commercial affiliate compliance and audit programs, consisting of 55 commercial affiliate service, operations and distribution sites Responsibility for directing the Abbott Laboratories supplier audit program, consisting of ~ 2000 suppliers, third party manufacturers and critical service providers. Abbott Laboratories Diagnostic division interface between outside regulatory bodies

Abbott Park, Illinois, Us

Multi-site responsibility for quality system remediation efforts and performance of FDA readiness audits for 4 Abbott Diagnostic manufacturing facilities located across Europe for FDA inspections and other regulatory bodies Perform FDA simulated inspections at European sites to prepare subject matter experts on how to answer questions appropriately in the presence of FDA Development, scheduling and performance of internal audits and conducting follow-up evaluations on corrective actionsManage site Quality System remediation project for FDA inspections at Third Party Manufacturers located in Asia Conduct in-house training on FDA inspection techniques and regulatory compliance requirements

Marlborough, Ma, Us

Site Quality Systems Manager, responsible for FDA inspections as well as ISO 13485 complianceEnsure site quality system is prepared for any external/regulatory audits, including the management of FDA inspection activities. Responsible for follow-up communication between FDA/Regulatory Bodies regarding requests for additional information, CAPA progress. Responsible for scheduling and conducting cross-functional audits of quality systems, produce audit reports and conduct follow-up evaluations on corrective actions which address non-compliance concerns. Responsible for the site CAPA program which includes conducting follow-up evaluations on corrective actions which address non-compliance concerns. Responsible for scheduling and conducting supplier audits. Responsible for site Calibration and Preventive Maintenance program.Complete Quality System Assessments for all areas of responsibility.Conduct in-house training on audit techniques and regulatory compliance requirements.

Marlborough, Ma, Us

Post Market Surveillance responsibilities, including complaint investigations and Field Action activities.Responsible for planning and leading all activities of the failure analysis process for OEM product related customer complaints. Responsible for the QA review and closure of investigations to allow for timely MDR submissions. Recruiting and managing staff of engineers who were responsible for the investigation of complaints from products manufactured by external suppliers. Manage complaint handling laboratory and product decontamination technicians. Established and ensured compliance with policy, procedures, and regulations applicable to Post Market Surveillance complaint handling (e.g. FDA 21 CFR Parts 820/803/806, ISO 13485:2003).Interfaced with OEM’s, engineering, clinical/medical, and other functional representatives to facilitate and execute complaint closures.Led all activities related to field actions – Product Recall, Customer Notifications, Safety Alerts, and Market Withdrawal.

Round Rock, Texas, Us

Development and implementation of the global supplier Quality Management System (QMS) audit programResponsible for planning, scheduling, execution and reporting of supplier audits, primarily located in China, Philippines, Thailand, Eastern Europe and Mexico.Recruiting and managing staff of auditors responsible for the audit activities of external suppliers. Review, edit and approve all audit reports prior to distribution Development and implementation of Quality Management Systems at supplier sites to adhere to required standards. Established training program for supply chain employees on administrative SOPs and pertinent regulations and industry standards. Conduct in-house training on audit techniques and regulatory requirementsMonitoring of Supplier Corrective Action Requests to ensure appropriate follow-up of action items prior to closureImplementation and monitoring of key quality system performance metrics

Round Rock, Texas, Us

Healthcare Compliance, Ethics & Regulation Certification Program

Msc In Technology Management

Bachelor Of Engineering, Electronic Engineering