scalable, allowing personalised therapies to be affordable for more people. To commercialise their technologies, they are recruiting a Quality Manager to lead them through ISO 9001 and other regulations. This would include developing and building quality frameworks for all stages of project development and manufacture through the management of … all stakeholders. Requirements: Graduated with a bachelor's or master's in engineering or similar. Substantial demonstrable experience leading a company through ISO9001/13485 relating to medical device instrumentation development and manufacture. Further exposure to GMP manufacture for biological products would be desirable. Comprehensive experience with “quality management … offer is a healthy benefits package including private medical insurance (including immediate family dependents), enhanced company pension contributions and annual bonus. Keywords: ISO9001/13485, Quality Management, Auditing, Medical Devices, Regulations, Development, Manufacture, Cambs/Herts Border Another top job from ECM, the high-tech recruitment experts. Even if more »
manufacturing. Maintain accurate documentation and lab records. Introduce innovative technologies and make informed recommendations. Manage project scopes, resources, and budgets effectively. Ensure compliance with ISO13485 standards. Requirements: Essential: Bachelor's degree or higher in a biological-related discipline, with significant post-qualification experience. Minimum of 3 years … experience in people management. Proven ability to lead, motivate, and mentor a team of scientists. Thorough understanding of product design control and ISO13485 regulations. Extensive experience in molecular biology techniques such as FISH, PCR, DNA manipulation, and fluorescent labelling. Previous work in a regulated, diagnostic environment. Strong … software tools such as BLAST/BLAT and sequence searching methods. Comprehensive knowledge of genomic principles and databases. Additional management experience preferred. Experience in ISO 9001 and ISO13485 compliant environments, including participation in audits. If you are ready to make a significant impact in a research more »
would be a strong benefit to have knowledge of NGS and molecular testing methods An appreciation of the regulatory requirements for a clinical laboratory (ISO 15189) and/or IVD, ISO13485 Good written and verbal communication skills, and able to work effectively in a busy and more »
with design control standards. Background in the medical device sector to understand regulatory requirements and quality management systems (QMS) essential for successful product development. (ISO13485) Knowledge in mechanical engineering with a focus on testing equipment and innovation in product development. Requirements: Bachelor's degree in Electronics or Mechanical Engineering. Up more »
Minimum of 5 years’ experience in developing software and troubleshooting hardware issues. Previous involvement in regulated In Vitro Diagnostic (IVD) development, including operating under ISO13485 and IEC62304. Significant experience in formal software verification Proficiency in C/C++ programming languages. Experience with Real-Time Operating Systems (RTOS) and bare-metal more »
