Quality Assurance Specialist

1 month ago

Espoo, Uusimaa, Finland Euformatics Full time

{"h1": "Quality Manager Role at Euformatics", "p": "At Euformatics, we are seeking a highly skilled Quality Manager to play a pivotal role in building and maintaining processes and quality systems that support our mission to deliver safe and efficient clinical diagnostics tools for hospitals and laboratories analyzing patient samples.", "ul": [{"li": "As a Quality Manager, you will be responsible for defining and documenting key processes necessary for quality management systems, ensuring high operational quality of our product development and commercial activities."}, {"li": "You will act as a crucial gatekeeper between our customers and the development team, ensuring that the releases we deliver have been thoroughly tested and documented according to the QMS."}, {"li": "Hands-on software testing for the releases is part of the job, allowing you to experience the product firsthand."}, {"li": "You will also participate in client projects as a quality representative, ensuring compliance with regulatory requirements for clinical NGS test development, validation, and verification."}], "h2": "Key Responsibilities", "p": "Your key responsibilities will include:", "ul": [{"li": "Interpreting IVDR requirements and translating them into product features and process descriptions for our internal R&D and joint projects with customers and partners."}, {"li": "Transferring knowledge efficiently to the development team about existing and new requirements from international quality standards and EU regulation for IVD devices."}, {"li": "Guiding the development team in the day-to-day documentation of our activities."}], "h2": "Requirements", "p": "To be successful in this role, you will need:", "ul": [{"li": "Attention to detail, as QMS development and maintenance rely on getting the details right."}, {"li": "Strong interpersonal skills and the ability to take leadership when needed."}, {"li": "Fluency in English (no Finnish required)."}, {"li": "A university degree or late-stage studies."}], "h2": "Nice to Have", "p": "While not essential, experience in the following areas would be beneficial:", "ul": [{"li": "Understanding and experience of ISO 13485 and IVDR."}, {"li": "Experience in software/release testing."}, {"li": "Knowledge or experience of software development, particularly in the field of bioinformatics."}], "h2": "What We Offer", "p": "As a Quality Manager at Euformatics, you will have the opportunity to make a real impact on the way diseases are treated. You will be part of a tight-knit, supportive team of specialists who share the same mission and purpose. We offer a dynamic and international work environment, flexible working hours, and the chance to work at the forefront of technological and regulatory change in a field that is already affecting the way we live.", "p": "We are looking for someone who is committed to our mission and is in this for the long term. If you are passionate about quality management and want to make a difference, please get in touch.", "p": "Please attach your CV and tailored cover letter for the position.", "p": "This position will be filled as soon as a suitable candidate is found.", "p": "#J-18808-Ljbffr"}

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