John Webber Email & Phone Number

Gothenburg, SE

Vastra Gotaland County, Sweden

 Responsible for the Global Document Management system, which involves implementation of continuous improvement and rollout across the business (HQ, manufacturing and commercial sites). The rollout involves the replacement of the local document processes (paper based or electronic) to to one global document solution. Responsible for the Global Compliance.

Vastra Gotaland County, Sweden

Responsible for the ongoing development, implementation and management of the Neoss Global Quality Management System (QMS).  Ensure alignment and compliance to ISO: 13485, GMP, FDA, other ISO and ASTM standards etc.  Responsible for all notified body/FDA communications. Schedule, chair, manage all the audits and resolve to closure of identified issues. .

Vastra Gotaland County, Sweden

Lead and manage all aspects of the site Quality System.  Ensure alignment to ISO: 13485, GMP, standards etc.  Manage site internal program and all aspects associated with external/notified body audits.  SME in compliance systems (both paper based and electronic), process simplification and alignment.

Stockholm, Stockholm County, Sweden

 QMS Design & Development.  SME expert in assessments of Quality Management Systems. Identify and implement QMS process redesign to streamline, simplify, and reduce resource needs whilst maintaining/increasing effectiveness and compliance. Expert in QMS processes (both paper based and electronic) such as Nonconformance/CAPA, Internal Auditing, Management.

Dublin, County Dublin, Ireland

 Working in a site QA team of two. Sole site Quality Assurance Engineer leading in the implementation, integration and maintenance of AMO Irelands Quality Management System (QMS), to comply with ISO: 9001/ISO13485 Standard both on site and with Technical Field Service Engineers based throughout Europe/Middle East/Africa. Key job functions include:  Site.

Cork, County Cork, Ireland

 Sole quality representative on evenings with which I was heavily involved in ensuring the quality of a medical device product from ‘Development Phase’ through to ‘First Human Use’ and ‘Build at Risk’ whilst awaiting product release.  Involved in MES/SFP batch and documentation review, complete station and line audits, isolate non-conforming material and.