Alan O'Sullivan
Recall Coordinator DePuy Orthopaedics
- Location
- Ireland
- Industry
- Medical Devices
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Alan O'Sullivan's Overview
- Current
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- Recall Coordinator at DePuy Orthopaedics
- Past
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- Recall Coordinator at DePuy Orthopaedics
- QA Manufacturing Support Engineer at DePuy Orthopaedics - Ireland
- Education
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- UCC
- North Monastery Cork
- Connections
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115 connections
Alan O'Sullivan's Experience
Recall Coordinator
DePuy Orthopaedics
Public Company; 1001-5000 employees; Medical Devices industry
December 2011 – Present (1 year 7 months) Cork
Co-ordinate and manage Recalls (Field Safety Corrective Actions) associated with DePuy Orthopaedic, Spine and Trauma products on International markets. Manage these activities in line with global medical device regulations and internal standard operating procedures.
MAIN DUTIES & RESPONSIBILITIES:
•Co-ordinate and manage Field Safety Corrective Actions associated with DePuy Orthopaedic, Spine and Trauma products on global markets .
•Support the creation of relevant recall documentation including Field Safety Notice, Field Safety Corrective Action form any market updates
•Undertake vigilance (recall) reporting in line with MEDDEV 2.12-1
•Coordinating and responding to enquiries related to recalls this will include Competent Authorities / Health Ministries / surgeons / Patients / Lawyers / Affilaites / Distributors /Internal colleagues as appropriate
•Partnering with manufacturing and design centres to co-ordinate recall actions
•Ensuring complete reconciliation of recalled inventory that were subject of a field action by maintaining records of product disposition and returned products
•Maintain field action files as per procedural requirements and SOP’s
•Ensure appropriate escalation in line with SOP’s undertake recall reporting on EDGE2 ensuring that logging, updating and closing are performed in line with corporate reporting requirements
•Manage and maintain the product global hold and quarantining process to ensure effective timely segregation and maintenance of product disposition records
•Support company initiatives with respect to process improvements to recall and global hold/bonding activities
•Assist in the investigation and closure of complaints as and when required
•Established internal primary point of contact for recalls in International markets
•Assist in developing and implementing global policies and procedures
•Provide periodic training for company personnel on the company’s recall processes and procedures
Recall Coordinator
DePuy Orthopaedics
Public Company; 1001-5000 employees; Medical Devices industry
2010 – 2012 (2 years)
QA Manufacturing Support Engineer
DePuy Orthopaedics - Ireland
Public Company; 1001-5000 employees; Medical Devices industry
March 2003 – January 2011 (7 years 11 months)
MAIN DUTIES & RESPONSIBILITIES:
•Actively support all Compliance Initiatives with the Value Stream and Plan
•Actively support all defined Value Stream and Plant goals and objectives.
•Work as an integral member of authorised Value Stream Process Excellence initiatives
•Identify projects to resolve scrap, reprocessing and special causes that have a negative impact on Value Stream and Plant Goals and Objectives.
•Compile Quality Process Specifications for new/transferred products/processes
•Validate new/changed production
processes/systems with Business Unit personnel
•Design and validate Quality System processes where appropriate (CSV and Inspection Process)
•Reviews product designs, test protocols and co-develop critical characteristics/tolerances for initial testing and validations and subsequent routine manufacturing controls.
•Conduct internal Quality System Audits as necessary
•Participates in design evaluations where appropriate
•Participates in process evaluations (e.g. FMEAs).
•Devises and implements methods and procedure for inspecting, testing and evaluating plans for subsequent routine production.
•Support Quality System activities within manufacturing cells such as Internal Audits, complaint investigations, close call and corrective action investigations.
•Perform/document dimensional/visual inspections and non conformance and deviations as required
•Manage a variable workload to meet operational requirements.
•Ensure that all Health, Safety and Environmental requirements are fulfilled
Alan O'Sullivan's Skills & Expertise
Alan O'Sullivan's Education
UCC
Cert, Supply Chain Management
2010 – 2011
Currently studying for Diploma in Supply Chain Management in UCC Level 7
North Monastery Cork
Alan O'Sullivan's Additional Information
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