Stephen Skull Email & Phone Number

Cambridge, United Kingdom

Responsible for ensuring that all products are designed, engineered and tested in compliance with applicable domestic and international regulatory standards for medical and healthcare products.

Houghton Regis

To ensure compliance of all Group Information Systems and make sure that good Computer System Validation (CSV), Change Control and Good Document Practices (GDP) are applied in accordance with internal and external regulations, e.g. GAMP 5, 21 CFR Part 11.

Houghton Regis

Managerial responsibility for 3 Technical Publications teams based in UK, Sweden & USA (Total of 14 employees).Responsible for all Product Labelling for Arjohuntleigh products including Device Labelling, IFUs & Service Documentation.Responsible for the budget of the 3 teams and all technical publications contractors including agreeing contracts and invoicing.Responsible for creating a global technical publications directive and procedures. Developed and coached direct reports to take more responsibility within the new labelling process. Driving consistency and new templates across the 3 sites.Process improvements including creating a global SharePoint site to centralise all information.Moved the Tech Pubs group to single translation supplier and setup new order process on MRP system for efficiency, quality and 25% cost savings (150k/yr).Supporting technical product owners for production sites in Poland and China.

Luton, United Kingdom

Managerial responsibility for the Engineering Team supporting ArjoHuntleigh’s Medical Devices, encompassing Production Support, Engineering Change Management, Complaint Handling, Technical Service Support & Publications.IEC60601-1 3rd Edition - Gained approvals for all current ArjoHuntleigh medical devices.ISO14971 Risk Management - Gained approval of new Risk Management process by outside certification house and implemented new risk management for IEC60601-1 3rd edition.Engineering Change Management – Design authority for all medical devices for production sites in Poland and China.FDA Audit support for Production Sites (Poland & China).Technical Files and Design Master Records – Maintained the Tech Files and DMRs for the Medical Devices.MRP Systems – Maintained data interrogatory for multiple MRP systems within the business (MAX & M3).Coordinated CAD project to upgrade system from IDEAs to SolidWorks.Product Testing - Provided Pressure Relief Index (PRI) & Pressure Area Index (PAI) testing for the business.

Luton, United Kingdom

Managerial responsibility for the Engineering product support team.Line manager for the product support team, both permanent and contract staff. Developed and coached direct reports to take on more responsibility with the aim of creating a more tiered department structure. Responsible for recruitment within the product support team.Product Support – Responsible for the product support of all current T&P product portfolio from manufacturing and warehousing through to sales and marketing. Allocates and prioritises engineering tasks based on cost saving, quality and business criticality.Engineering Change Management – Managed all Engineering Change Notes (ECN). Developed a new ECR/ECN procedure encompassing production sites and warehouses in Poland, China & Holland.Technical Service Support – Supports the business with technical service support for both new product introduction and legacy products. Responsible for training the senior service staff of the global service organisation.Publications – Managed Publications dept, delivering documentation/labelling for New Product Development (NPD) and Engineering Product Support.Managed technical files and regulatory documentation for Medical Devices.Rationalised the T&P product ranges from approx 360 SKUs down to 70 and gained UL approval for the rationalised range. This was a major cost saving to the business.Developed, transferred and maintained the product Master Device Records which enabled design transfer to take place to the new Production Facilities in Poznan & China.Provides design authority input into the group data management system (M3) project. Is responsible for all data cleansing and implementation of a local item master procedure.

Luton

Managerial responsibility for the Technical Publications department which produced user and service documentation for Medical Devices. Team leadership skills range from department workload planning and ensuring delivery to specific project timescales, to conducting regular team meetings, staff appraisals and training.Managed the Engineering Change System and deputised for the custodian of changes on a day to day basis. Responsibility for the mattress testing facilities. Developed and introduced for the first time a database for the control of testing data and archive information.Designed and published a user and service documentation CD, distributed to customers and service centres throughout the world.

Luton, United Kingdom

Managed the day to day running of the Publications department supporting a wide range of products.Recruited a team to strengthen the Publications department and organised relevant training to further improve the Publications resource within the company.Created an Access database to control workload and issue control of documents.

Luton, United Kingdom

Responsible for creating user and service manuals for Medical Devices in the Pressure Area Care and Intermittent Compression product ranges. Designed new templates to make the documentation more professional.

Welwyn Garden City

Maintained aircraft manuals for Raytheon, implementing modifications into Component Maintenance Manuals to ATA100 standard utilising Adobe Framemaker.Produced SGML electronic documentation linked to Illustrated Parts Lists for a Norwegian oil rig company using Simplified English for a wide variety of equipment.Designed and developed new and existing relational databases to reduce duplication of information and help with cost analysis of contracts.

Letchworth

Completed technical authoring apprenticeship and attended college achieving an HND Engineering qualification.Produced technical manuals to internal/external standards e.g. Ministry of Defence standards AvP70, ATA100, DEF-STAN 00-60.