3 ISO 13485 Jobs in Hertfordshire

of diagnostic technology! Due to the imminent global release of this product, you will need to adhere to the requirements of medical device regulations – ISO 13485/FDA environments. As the Senior Verification & Validation Engineer, your responsibilities will include: Lead the planning of verification activities for the system … Instrument and test consumable. Ensure tests are designed in alignment with product requirements will full traceability. Adhere to the requirements of working in an ISO 13485/FDA regulated environment. Implement verification and validation test plans and protocols for the system/product, documenting all activities within the … degree or equivalent hands-on experience. Recent and relevant practical experience in verification of In Vitro Diagnostic (IVD) devices or medical devices in an ISO13485/21CFR regulated environment. Experience in writing, editing, or addressing product requirements. Proficiency in both Mechanical and Electrical Engineering disciplines. Track record of submitting regulated more »

CAP, ISO15189 laboratory requirements Experience in CLSI, NYDOH and other industry standards for assay validation; Understanding of IVD regulations including QSR regulations, GMP manufacturing, ISO13485, and FDA and EU medical device regulations. Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do not have more »

team in performing environmental monitoring in line with the requirements of Standard Operating Procedures (SOP's). Follow all requirements of working in an ISO 13485/FDA regulated environment. The Senior Quality Control Scientist will have the following skills and experience: Batchelors degree in Molecular … biology or similar (or equivalent experience). Recent and relevant in Quality Control for In Vitro Diagnostic (IVD) devices and or reagents within an ISO13485/FDA regulated environment. Hands on experience of PCR and understanding of underlying principles. Familiarity with operating under formal quality systems and practices, such as … ISO13485 and FDA regulations. Practical experience within the Life Science industry would be a distinct advantage. Interested or know someone who might be? If so, get in contact with Darren Holmes @ Vector Recruitment Ltd on 01234 815474 or more »