The QA Engineering team has a significant role in ensuring safe, reliable and compliant products during new product development and maintenance of existing product platforms.
This is done by cooperating, supporting, facilitating, training and communicating towards the best results with partners in R&D.
This Manager position is located in Poland and is to lead a team of 3 highly skilled engineers in Poland. The QAE Poland team has the responsibility of Approval of documents related to Labeling and Sterilization.
This team is part of the bigger QAE team in Denmark. We support design control for Blood Gas (ABL, Transcutaneous monitoring and sterilized sampler products) and IT System solutions and works cross functional with our QA Colleagues supporting design control for Immunoassay, QA-Operations.
This position reports to the Senior Manager of QA Engineering in Radiometer Denmark.
Managing the QAE team with Design Control responsibilities for Sterilization and Labeling
Review and approval of documents related to Design Control
Ensure activities required by QA are fulfilled according to project plans.
Strengthen relation / integration with stakeholders
Continuous improvements of sterilization and Labeling processes and collaboration with sterilization partners and Suppliers (implementation of current legislation at suppliers)
Provide guidance for QMS and regulatory compliance in an FDA regulated and ISO compliant environment.
Represent Quality Assurance in design and development projects and on cross-functional teams supporting new product development, agreeing and planning for requirement management and approving documentation.
Collaborating closely with R&D, Operations and RA to assure high quality throughout the development process including design transfer and post launch activities.
Take part in the Quality assurance activities as an active member of relevant project teams.
Participating in quality training activities.
Keep updated knowledge of standards, regulatory requirements and directives applicable for Medical Devices / IVD and ensure updating relevant parts of the QA system.
The ideal candidate holds a Masters degree, with strength in product design processes of multi-disciplinary products. However, if the candidate has a good technical understanding and is able to learn the technical aspects in the products fast and to communicate in a technical organization, other education at university level relevant for QA work could be accepted.
Passion for working as a people Manager
Experience of working with design control processes in one or more of the following areas : Risk Management, Usability, Requirement management, systems engineering and architecture, Validation and verification, Design planning, Labeling, Sterilization.
5-10 years of QA Design Control experience from the medical device or IVD industry or other similar regulated industries.
In-depth knowledge of relevant standards and regulations in USA, Canada, Asia, Europe and other key markets (FDA, ISO, MDR, IVDR, MDSAP and MDD)
Process development and lean thinking.
Has experience of working with multicultural and in a matrix organization
Structured person with skills for planning and visual management.
Drives projects forward to reach pivotal objectives and makes things happen and follows through
Fluent English in writing and speaking