1 to 7 of 7 ISO 13485 Jobs in the East of England

At least 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 and bare-metal development more »

requirements. Qualifications and experience Essential: Degree in law, medicine, pharmacy, engineering or another relevant scientific discipline At least 3 years’ experience working in an ISO13485-certified quality management system for devices that require review and approval by authorities (e.g. FDA, Notified Body, UK Approved Bodies). Excellent attention to detail … organisational, team-working and communication skills. Experience managing a quality system, ISO compliance and internal and external audits. Proactive thinking, designing and implementing processes from scratch and working collaboratively in a small, fast-paced and interdisciplinary team. Motivation to learn and continuous improvement mindset. Preferred: Experience working with technical … with quality for Software as a Medical Device products and/or connected devices Experience supporting a Quality Management Rep Hands-on experience with ISO13485 audits 52North is an equal opportunity employer and is committed to providing equal employment opportunities to all employees and applicants for employment without regard to more »

and resolve issues. Perform formal software verification. Qualifications To succeed in this role, you should have: Experience in regulated IVD development, including compliance with 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 »

regulatory processes are followed meticulously. Report any QC pass and fails, monitoring any non-conformance closely and taking corrective action. Strictly adhere to all ISO 13485/FDA regulations. Follow SOP’s, maintaining accurate records and document all production activities in accordance with company policy. Your background: BSc … or equivalent in a Biological discipline (or related). Background in an IVD development setting, working to ISO 13485 standards in a production or QC team. Proven industry/commercial lab experience, ideally where there are devices in development. Good proficiency with RT-PCR along with other classic more »

also take on quality management responsibilities as Management Quality Representative, becoming responsible for all aspects of the QMS, including: Achieving and maintaining full-scope ISO13485 certification Approving QMS records Delivering on quality objectives Ensuring quality training is up to date for all staff and that staff understand and follow QMS … marking/FDA approval for a new-to-market Class II/III/Class C/D IVD. Experience managing a quality system, ISO compliance and internal and external audits. Excellent organisational, team-working and communication skills. Proven track record of delivering projects, proactive thinking, designing and implementing … and/or connected devices Experience gaining regulatory approval for a self-test Experience as a Quality Management Rep or PRRC Experience with gaining ISO13485 certification from scratch Experience working in a Notified Body or equivalent 52North is an equal opportunity employer and is committed to providing equal employment opportunities more »

and resolve issues. Perform formal software verification. Qualifications To succeed in this role, you should have: Experience in regulated IVD development, including compliance with 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 »

Experience working with early-stage products. Experience developing approval ready devices and products. Experience with C++ & C also useful. Experience within Medical Devices Sector (ISO 13485). If interested, please apply, or reach out for further information about the role more »