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.

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.

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 –.

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.

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.

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.