Head of Quality & Regulatory Affairs

Job Description

Who we are

Every life is unique and so are you!

At Dräger we protect, support and rescue lives day in and day out. We are interested in you if you have the desire to work for an organisation that does something more, something that is truly worth working for.

As an international leader in medical and safety technology, we develop pioneering devices, software, services and solutions that people around the world trust. Wherever Dräger products are used, it’s about the most important thing: it’s about life.

Employment Type: Full-Time

Industry: Engineering

Location: Blyth, Northumberland

Postal Code: NE24 4BQ.

About the role

The Head of Quality & Regulatory Affairs manages the entire quality area of the Safety Division UK

The function ensures that demanding quality targets are realized and that the targeted economic goals (growth and profitability) are achieved.

The area of responsibility includes Supplier Quality Assurance, Production Quality, and Quality & Regulatory Affairs including product quality and reliability engineering.

The job holder will work very closely cross-functionally with colleagues in the Business Fields, Research & Development and Supply Chain of the Safety Division as well as Global Sales & Service and Quality in the Safety Division as well as Corporate Quality.

General Responsibilities

• Overall management and leadership of the entire quality area of the Safety Division UK
• Strategic, conceptional and operative management, leadership and development of Supplier Quality Assurance, Production Quality and Quality & Regulatory Affairs
• Responsibility for the achievement of agreed targets and key performance indicators
• Agreed targets and key performance indicators refer to quality key figures as well as the improvement in earnings (EBIT) of the related business
• Operate and continuously improve the quality management system at all sites to sustainably support Dräger’s strategy and the company’s values
• Ensure that Dräger Safety’s UK Ltd.`s quality management system is compliant with the various relevant regulatory and legal requirements and standards
• Provide leadership to the quality functions ensuring there is a clear and common objective, guidelines, and priorities
• Develop the staff working in quality functions so they have the skills and competencies required to perform their roles
• Monitor performance of quality staff and improve where necessary, if necessary, taking disciplinary action
• Representation of Dräger Safety UK Ltd. in internal and external audits

Quality / Environmental Management System

• Implement corporate standards into the localised Integrated Management System within the specified effective date, improve and monitor effectiveness of the IMS
• Ensure compliance with relevant directives, standards, technical and regulatory requirements and assure the achievement of quality and environmental targets
• Implement and maintain an internal audit program
• Ensure that external certification/approvals are maintained, addressing any identified nonconformities within the timescales specified.
• Generate Quality and Environmental targets and initiatives to support the business needs based on corporate, regulatory, and local requirements. Report performance against these targets and initiate corrective action when required
• Communicate within the leadership team and throughout the business to ensure that the Quality and Environmental ethos is shared and maintained
• Advises Q&RA and other functions regarding the development and implementation of new government/regulatory developments and regulatory strategy
• Develop, implement, and review current policies and practices issued by regulatory agencies. Participate in industry groups to ensure Company is kept current on all pending regulatory changes and that the Company position is made known and/or represented.

Product Quality, Supplier Quality Assurance, Production Quality and Safety

• Define demanding quality targets, analyse, and measure performance, improve where required (e.g., by using CAPA), control the effectiveness
• Assure high product quality in Sourcing and Production and by early involvement in the new product development process by the deployment of Reliability Engineers and implementation of the new product development process supported by best practice methods and tools
• Ensure that Customer claims are handled in an effective and efficient manner to the timely satisfaction of the Customer
• Promote awareness of customer requirements, monitor quality performance, and communicate customer quality issues and resolution thereof
• Conduct the market surveillance, therefore closely interact with corporate partners, e.g., subsidiaries, and generate product improvement programs in close cooperation with involved functions as e.g., R&D, Production, Purchasing and Product Management
• Generate product improvement programs in close cooperation with relevant functions
• Assure device vigilance and complaint handling responsibilities
• Assure fulfilment of device reporting responsibilities
• Maintaining and deploying an analytical approach to problem solving utilising the recognised techniques of Lean Six Sigma, 8D, etc.
• Leadership in continuous improvement initiatives to meet business needs
• Assure that product quality requirements are fully implemented at every location that manufactures/modifies (LVA) CABE products