The Quality Manager drives Quality and continuous improvement process and culture within the organization. The Quality Manager is the site Quality Head and reports to the Business Assurance & Compliance Director.
As our Quality Manager, you influence our Quality Management System and ensure the success of our organisation. You have a passion for Quality and want to make an impact on our patients.
The specific responsibilities are amongst others:
You develop, maintain and promote Quality within the organization
You maintain our Quality Management System and are accountable for its improvement
You maintain compliance to the required norms and standards (e.g., ISO 9001)
You drive daily operational improvements
You ensure that the processes and procedures are supporting the business
You are accountable for our internal and external audit programs: planning, preparation, execution & reporting
You support Process Owners to improve processes within the organisation.
You are responsible for the oversight of Records Management and you are it’s local ambassador and act as primary contact point for employees for all record management related questions. You establish and maintain inventories and associated retention times together with identified stakeholders in departments. You will set-up and maintain record management related policies and procedures
Who you are
You are a convincing communicator able to follow through with the virtual teams you create. You are an experienced project manager able to combine ground work and strategic work.
You have a Bachelor or Master degree
You have at least 5 years of experience in a Quality role (process management, supporting business, … ).
You bring experience with ISO standards, such as: ISO 9001, ISO 27001.
Proven experience in managing audits is required
You bring along several years of experience in Quality Management positions and a relevant formal education.
You think strategically, inspire people with your ideas, and by that create a stimulating and motivating workplace capable of spreading the Quality mission
Collaboration across hierarchies and organisational units is important to you and you actively drive it. You build stable networks that bring the organization forward
You bring a mindset geared towards continuous improvement
Ideally, you are aware of Roche Diagnostics' product and service portfolio, the market and competitive situation
Ideally, you have experience in the regulatory framework for IVD Medical Devices
You demonstrate excellent written and verbal communication skills
Languages: Dutch, French and English