Head Of Quality

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Head Of Quality

ARM have a new Senior opportunity available for a Head of Quality with a globally recognised blue chip Medical Manufacturer. As a Head of Quality you will have experience of working within the Medical Device industry with an understanding of FDA, CFR and ISO13485.

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:
What are my responsibilities?
- To ensure compliance with 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 the company Quality Management Systems.
- To comply with all company Health and Safety policies and procedures.
- Facilitate methodologies to analyse customer requirements appropriately in order to meet customer expectations and to identify relevant KPIs for quality reporting.
- Ensure;

a) identification of critical business issues, (b) prioritisation of improvement projects/actions, (c) realistic budget and resource planning, (d) selection of financial and non-financial KPIs, (e)benchmarked target values and, (f) the coordination of personal quality-related targets for management, individuals and/or teams.

- The development, implementation and documentation of a consistent quality management system based on regulatory and quality-related requirements.
- 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
- 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.
- To plan and coordinate continuous improvement with top management.
- Ownership for audits, assessments and preparation of management reviews, this includes regular internal assessments based on the mandatory elements of the our
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

What do I need to qualify for this role?
- Communicate effectively, providing relevant information in a timely manner, both verbal and written, with direct reports, peers, line management and your customer base to build trust and cooperation across the business.
- Expert knowledge in Quality principles and international regulations and standards (ex. ISO 13485, 21 CFR 820)
- Working knowledge of healthcare products and associated quality and continuous improvement projects
- Experience in highly matrixed corporate environment- National certification in a Quality discipline (auditing, quality engineering etc.) is a plus.



Please contact Cassie Moore for more information.

Head of Quality, Quality Director, Director of Quality, QMS Director

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

Cassie Moore

cassie moore profile

The typical job roles which I recruit for include Project Engineers, Project Managers, Electrical / Mechanical Engineers, Electrical / Mechanical Fitters, Quality Engineers, Reliability Engineers, RAMS Consultants and Senior Management. I currently work within the Manufacturing & Technologies…