Danaher Corporation QA Specialist for Sterlization (f/m/d) in Stargard Szczecinski, Poland
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.
The position is working as Sterilization Specialist; located in Poland. 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.
We are currently looking for an experienced candidate for the position of QA Specialist for Sterlization (f/m/d) to join Stargard, Poland team. Role will report to the Senior Manager of QA Engineering-Blood Gas in Radiometer, Denmark.
Ensures activities required by QA are fulfilled according to project plans.
Supports review and approval of validation and requalification of EO sterilization processes.
Continuous improvements of sterilization collaboration with sterilization partners and Suppliers (implementation of current legislation at suppliers).
Provides guidance for QMS and regulatory compliance in an FDA regulated and ISO compliant environment for Sterilization.
Takes part in the Quality Assurance activities as an active member of relevant project teams.
Keeps updated knowledge of standards, regulatory requirements and directives applicable for Medical Devices/IVD and ensures updating relevant parts of the QA system.
Master´s degree, with experience of working with Good Manufacturing Practice and Good Documentation Practice.
Working experience: 3-5 years’ experience with “Sterilization” and “Clean Rooms”.
In-depth knowledge of relevant standards and regulations in USA, Canada, Asia, Europe and other key markets (FDA, ISO and Medical Device Directive) ideally in branches like pharma, food, medical devices.
In depth knowledge of ISO-11135 and ISO-8 within “Sterilization” and “Clean rooms”.
QA Design Control experience from the medical device or IVD industry or other similar regulated industries.
Good technical understanding and is able to learn the technical aspects in the products fast.
Stress-tolerant, decisive, energetic, attentive to detail, persistent, proactive, lean thinking.
Fluent English fluently in writing and speaking
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