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 Training process, which involves implementation of continuous improvement and in the rollout across the business. Implemented a significant redesign in May2022 involving a controlled global training matrix then interfaced with the electronic training solution to which training packages are electronically assigned. Other implemented training activities include (A) implementation of a training calendar to enable global employees to upskill, (B) significant strengthening of training effectiveness which involves moving the program to Read & Understand with connected training effectiveness and classroom training.  Audit Management. Responsible for managing notified body audits. In addition ISO13485:2015 Lead auditor certified and significant experience in executing internal, corporate and supplier audits. Responsible for the Global nonconformance and CAPA process, which involves implementation of continuous improvement and in the rollout across the business. Process redesigned in Mar2022 to implement a risk based approach and coding process to identify negative trends. Implemented an NC/CAPA Academy Training program to train core team on the requirements, the process and the tool.  Responsible for the Global Temporary Change Process, which involves implementation of continuous improvement and in the rollout across the business. Implemented a redesign in Sep2022 to strengthen the risk assessment, actions and closure. Responsible for the Standards, Regulations and Guidelines process which involves identification (new and revised), assessment and implementation within the QMS.

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.  Qualified Lead auditor to ISO:13485:2016. With that I manage and execute all internal audit and supplier audits.  Raise, document and manage the following processes e.g. document system, training system, supplier non-conformance, customer complaints & vigilance, management review.  Currently leading the site in the transition from the Medical Device Directive to Medical Device Regulations.  Currently leading the business on the project to transfer from paper based to compliant electronic systems.

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 Review, Document Control, Document Periodic Review, compliance training programs.  Manage the site non-conformity/CAPA process. Key job functions include:  Ensure non-conformities are raised and tracked  Ensure site metrics are tracked, reported upon and maintained  Provide SME guidance on the process  Manage responses the external/notified body audits. Key job functions include:  Ensure findings are addressed/implemented  Write and submit written responses  Track activities to closure/effectiveness  Management Review. Key job functions include:  Submit agenda and gather data from departments  Chair quarterly meetings  Write minutes & track open actions to closure  Manage the site internal audit program. Key job functions include:  Create, approve & manage execution of audit program  Execute internal audits (ISO:13485 Lead Auditor certified)  Mentor site auditors ( Certified Trainer)  Ensure findings are addressed/implemented  Quality Development. Assigned to assess and streamline compliance processes to simplify whilst ensuring compliance to regulations.

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 Lead Auditor managing the site internal audit team. (Lead Auditor Certified).  CAPA Co-ordinator. Manage the site CAPA system which I raise, review phases, complete effectiveness check and close all CAPAs. (CAPA Certified). Document Reviewer/Controller. Manage the review, process and release of new, revision and in the obsoletion of Quality Management System (QMS) documentation.  Site Compliance Trainer. Manage site compliance training (e.g. CAPA, Audit, Document Control, QMS) through classroom/WebEx conference media. (Certified Trainer).  Manage the Periodic Review Process.

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 in the review and update of process documentation such as SGOI’s and Work Instructions. Identify, raise, investigate, document and close non-conformances leading to implementation of effective corrective/preventative actions. Raise CAR/CAPA for a non-conformance when required.