Quality Assurance - Medical Devices - Specialist (Permanent)

Quality Assurance Specialist - Medical Devices

As Quality Specialist, you will play an important role in maintaining and improving the Quality Management System through document revision, quality training and process improvement initiatives.

You will work closely together with the different stakeholders from other departments in order to perform various change control, validation and calibration activities in compliance with corporate and local policies.

Other Key Responsibilities:

Ensure Quality Management System requirements are in accordance with European Regulations and ISO 13485, are effectively established, implemented, and maintained

Establish, implement, and sustain the Quality Management policy and principles

Works closely with other departments to ensure compliance and maintain the highest quality standards

Coordinate the various change control and validation projects and to make sure that the validation program is performed in accordance with the corporate and internal policies

In your role you will also be responsible for follow-up on calibration activities, you will be in contact with calibration suppliers and perform supplier evaluations

You will also be performing investigations and root cause analysis for CAPA's linked to the activities you are executing and will drive the implementation of corrective and preventive actions and validate its effectiveness

About You:

You have a Master or a Bachelor degree

You have experience in ISO13485 and European Regulations, such as MDR, IVDR, with exposure to document and data control processes

You have experience in internal audits

You have the ability to influence others and move toward a common vision or goal

You are able to work effectively at all levels in an organisation

You have excellent verbal and written communication skills in English

If this role suits your personal and professional profile, send your CV to myself, Christian Finnegan on the NonStop consulting website or to my LinkedIn. If you yourself are not interested in this opportunity however you know someone whom might be interested in a new role, please forward this job posting to them and help them expand their network.

NonStop is one of the largest and fastest growing specialised life-sciences & Med-tech recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland, Romania, Luxembourg, France, US and the Czech Republic and we hold labour leasing licences for all EU8 countries. Please visit our website for a full list of the niche markets we cover.