Head Of Quality

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Head Of Quality

My client is seeking a Head of Quality to work with and consult management to support the business by selecting, coordinating, directing, controlling, standardizing activities and initiating continuous improvement in order to become quality leader.

Job Description

Head of Quality
North Wales

My client is seeking a Head of Quality to work with and consult management to support the business by selecting, coordinating, directing, controlling, standardizing activities and initiating continuous improvement in order to become quality leader.

The successful candidate will report directly to the Site Operations Head and will be responsible for ensuring appropriate quality systems are in place facilitating the production of quality products in the most efficient manner possible.

Responsibilities:
- To ensure that staff responsible to you comply, at all times, with the relevant Quality Standards and Regulations, e.g. ISO 13485, US FDA Quality System Regulations (QSR 21 CFR Part 820), and relevant European Directives as documented within our company Quality Management Systems.
- Ensure that all staff comply with all company Health and Safety policies and procedures. To highlight any real or potential Health and Safety issues to management in a timely manner and assist in actioning their decision.
- Facilitate methodologies to analyse customer requirements appropriately in order to meet customer expectations and to identify relevant KPIs for quality reporting. Regular customer integration should be fostered with consequent usage of tools, as well as professional feedback and complaint handling to achieve high customer satisfaction/retention. Clear escalation process with fast complaint routing and consequent root cause analysis to satisfy the customer.
- Business driven quality planning
- Quality management system: Development, implementation and documentation of a consistent quality management system based on regulatory and quality-related requirements. - Embedded quality in processes and projects: Ensure implementation and controlling of quality gates and preventive quality tools to gain a sustainable higher quality in the processes/projects. Initiate continuous improvement with employee support. This requires personal involvement in processes and projects. - Focused, regular and direct quality reporting: Using key performance indicators, targets, budgets and process information, plan for and engage appropriate resources to achieve those objectives to the highest quality and cost effectiveness and put in place effective solutions for those not being met.
- Consequent supplier management: Ensure supplier management with best management methods, to increase the delivered quality and reduce the cost of non conformance. This comprises supplier-related processes like selection, information, development. integration, monitoring and auditing.
- Continuous improvement: Planning, initiative and coordination of continuous improvement with top management. Providing concepts and pragmatic tools like clear organizational roles, integration in process and project design, assurance of management attention and enough resources. Initiating best practice sharing. - Audit and assessments: Ownership for audits, assessments and preparation of management reviews, this includes regular internal assessments based on the mandatory elements of quality management guidelines.
- Directive leadership toward QM in processes/projects; intervention, overruling and escalation in case of process noncompliance; release and stop of delivery; access to all quality relevant data e.g. customer contracts, risk assessments, financial data, project plans, target settings; internal and external representation of the case of quality management system
Requirements:
- Ideally degree qualified in Scientific/Engineering or Business
- Working knowledge of healthcare products and associated quality and continuous improvement projects
- Excellent understanding of Quality principles and international regulations and standards (e.g. ISO 13845 or 21 CFR 820)
- National certificate in a quality discipline (auditing, quality engineering etc)
- Excellent communicator

Advanced Resource Managers Engineering Limited operates & advertises as an Employment Agency for permanent positions and as an Employment Business for contract/temporary positions.

Key Consultant

Wendy Gulliver

Wendy Gulliver Profile (1)

I specialise in the sourcing and acquisition of talent within the oil and gas market. I work with oil and gas professionals, as well as those seeking to transfer their skills into this exciting industry. The typical roles I recruit for include mechanical design, mechanical engineering, electrical design, project management, production and manufacturing.