United Kingdom
Technical communicator with wide experience in quality assurance, technical service and training. Analytical and adaptable, with excellent attention to detail, tempered with pragmatism in order to achieve effective and efficient results. Always seeking (to help others) to deliver service and information that is Right First Time.
Quality Systems Engineer and Management Representative coordinating, maintaining and improving all aspects of the formal Quality Management System for a manufacturing site and service centre handling emergency ventilators and infusion pumps within a global medical device corporation. Local procedural compliance to regulatory requirements and evolving corporate arrangements and document management platforms. Regulatory and NB audit management, follow-up and certification, Management Review, Complaints (SME), CAPA, Risk Assessment, Process Validation, Receiving Inspection, Nonconforming Product, Training, Engineering Change Control, Supplier Quality, Document Control, Technical Agreements, Legal Manufacturer responsibilities and support for Regulatory Affairs. Reduced internal & external audit findings from 40 per year to zero. Supported Anvisa and (two) FDA auits with no local findings.
Quality assurance throughout the supply chain. Customer complaint root cause investigation and corrective actions. Value-adding documentation for products and processes. Training and support to colleagues at all levels. Administration of key processes in ISO 9001-compliant quality management system, built on Customer Focus and Continual Improvement. Technical specifications for components, assemblies and processes to suit the context within the overall supply chain. Policies and procedures, tailored to their respective levels of the organisation, from global policy/framework for document control systems, to simple form-driven procedures. Designed and maintained an intranet site for user-friendly access to procedures and information. 80-90% simplification of documented quality management system. Rolled-out and supported 2 major complaint handling systems and trained users to the required levels. Supplier and Internal auditing (including training other team members). Calibration and uncertainty of measurement.
Technical support, reference material, troubleshooting and application advice, largely for non-native English speakers, translating customer questions and requirements into product/service-specific terms and vice versa. Engineering change control, configuration management, production engineering. Coordinated Y2K upgrade programme for products in the field. Designed & developed Triangle Solver utility program for angular & linear calculations.
Pre-production, engineering change, configuration management, component engineering, production engineering, test & inspection fixtures, product & process specifications, deviation control. ATE feasibility study.