Ensure products and services provided are fit for purpose, are consistent and meet both external and internal requirements, standards and regulatory compliance. Co-ordinate the activities required to meet required quality standards. Monitor and advise on the performance of the integrated quality management system, producing data and reporting on performance, measuring against set standards, and KPIs. Liaise with other managers and staff throughout the organisation to ensure that the integrated quality management system is functioning properly and where appropriate, advise on changes and how to implement them and provide training, tools and techniques to enable others to achieve quality standards and customer expectations.
MAIN CUSTOMERS / CONTACTS
3rd party Contractors
Global resources engaged in delivery of quality
PRINCIPAL ACCOUNTABILITES Responsibilities:
Develop and maintain the company’s quality management system and working practices to ensure compliance with ISO 9001 and ISO 27001 standards, regulatory requirements and customer contractual obligations.
Manage, review and monitor all 8D activities, Root Cause and Effect Analyses, and Corrective and Preventive Actions (CAPA) and ensure information is documented and that prompt actions are taken by responsible departmental managers and process owners
Collect and analyse measurable data from the company’s core and supporting business processes to determine the effectiveness and suitability of the Integrated Quality Management System deployed.
Prepare and present quality reports, data and Key Performance Indicators to management for review at quality review meetings
Maintain Quality System Dashboards, scorecards / Key Performance Indicators for the quality system processes. Review and monitor trends, communicating out-of-norm issues to department management.
Maintain the Integrated Quality Management System Quality Plan to identify and monitor quality tasks/goals which are critical to successful delivery of projects, products and services
Ensure awareness of customer requirements throughout the organisation to consistently provide products and services that meet customers’ expectations
Liaise with external parties and inter-company teams on matters relating to the quality management system and Information security initiatives
Establish an Internal Audit Schedule and conduct audits
Maintain the company’s Integrated Management System and Standards Library, core and supporting business process maps and periodically review for changes or revisions to advise the company of changes to standards that may have possible impact on the quality or information security system.
Assist in ensuring that the Head of Quality is kept fully appraised (via regular reports) of Quality issues , information security risks and Key Performance Indicators (KPIs) related to the local affiliate (including key suppliers). Liaise with affiliate functions and key suppliers in order to co-ordinate the provision of data for the report
Create Project Quality, Standards and Regulatory Plans for each new product development project to identify and document how the company will achieve requirements that are specific to a project or contract, which quality system processes to be used – and to ensure they are accomplished
Review and assist in applications of best practice quality tools and techniques, process capability studies and statistical techniques as necessary, to support continuous improvement. Initiate updates/tracking on status of core quality system processes
Conduct review of Change Control Requests, ensuring compliance with cGMP and quality standard requirements. Assist in the development of change control action plans. Follow up on recommended actions
Ensure that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with EDMI Europe company values
Participate in inter-company value-added continuous improvement initiatives and projects, liaising with Quality Managers in Singapore, Malaysia and Japan to improve our worldwide quality systems and standards for the organisation
Assist in ensuring that any potential quality risks to the company are managed in an appropriate fashion by utilising local Quality Risk Management procedures. Co-ordinate and manage the self-inspection & supplier audit programme according to the priorities determined by risk assessment
Develop and write Policies, Standard Operating Procedures, Work Instructions, and Process Flowcharts, Control Forms for functional departments within the organisation, as and when required or requested
EXPERIENCE AND QUALIFICATIONS
Graduate , preferably Engineering degree
Quality management experience
Knowledge of Information security and legislative requirements
Experience in implementing ISO9001 and ISO27001 system
Experience in auditing ISO9001 and ISO27001 systems
Ability to manage a complex, multi-phased project that develops and delivers a high-quality technical product
Excellent communication skills (Written & oral)
Excellent stakeholder management skill
Relevant experience of project management and delivery in a manufacturing and logistics area in conjunction with the design/delivery of similar electronic/telecoms based products
Proven ability to deliver projects through to high-quality implementation/deployment
Proven, effective customer management skills
Organised and diligent
Proven track record of meeting deadlines
Quality sampling, trend analysis and monitoring methods