26 to 50 of 119 ISO 13485 Jobs

accountabilities include, but are not limited to; * Supporting all other departments to ensure they remain compliant to the accreditations strategic to CIL. Primarily; AS9100, ISO 9001, ISO 13485 * Leading product quality in production, which would include containment, investigation, correction, implementation, and validation of corrective actions * Assisting in more »

internal audits and supplier audits as required Requirements: * Previous experience in Document control, quality assurance or similar * Experience working with QMS systems * Knowledge of ISO 13485 or ISO 9001 would be an advantage * Excellent attention to detail * Able to work as part of a team To be more »

engineering or science to degree level (preferred) Experience in a quality related role. Ability to inspect and measure produced parts (with experience) Experience of ISO 13485 or ISO 9001 Internal auditor qualification (preferred) Medical device manufacturing experience. Ability to communicate and liaise with different departments to ensure more »

work for a rapidly expanding medical device company. Our client is ideally looking for an experienced microbiologist who holds IVD related experience within an ISO 13485 or ISO 17025 setting. The Role Use specialised technical knowledge and skills to implement company research strategies to lead the development … mentoring junior staff members. Understanding of IVD medical device regulations. Experience working in a clinical microbiology laboratory would be ideal. Previous experience working to ISO 13485. Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will more »

products Excellent communication and interpersonal skills for client and colleague relationship-building Experience in team management (preferably Agile methodologies) BONUS POINTS FOR: Familiarity with ISO 9001 and ISO 13485 standards for medical device projects Background or experience with a design consultancy engineering environment Breadth of skills is more »

medical devices. The ideal candidate will have the following skills: - Experience in the development of medical devices - Compliance to medical device standards (IEC 60601, ISO 14971, ISO 13485) - Electronic circuit design (Altium) - Knowledge of German and English 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 »

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 »

software for their advanced diagnostic systems, collaborating closely with internal and external software teams. Role requirements: 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 »

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 »

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 »

doing Creating and documenting software for their future product pipeline. Follow all relevant medical device standards in the creation and documentation of software (notably ISO13485, ISO62304 and ISO14971). Write efficient, logical, and well commented and documented code. Perform the verification and validation of the code, including module, sub-system more »

of tests. Support the continuous development of IT processes (eg further development of internal CSV processes or certification of IT service areas according to ISO 27001: Information Security). Act as a key contact person as a CSV expert for customers & audits. Review & approval CSV & system documentation. Your Skills … Annex 11/FDA: 21CFR Part 11). Ideally experienced in the Medical Technology Sector. A knowledge of important IT Standards & Methods (eg ISO27001, ISO 80002-2, ITIL) or ISO 13485:2016 QMS for Medical Devices. Your Profile: Completed relevant Scientific or Technical University Degree. Strong communication more »

of continuous improvement. Provide training and support to staff on GDP compliance and quality assurance processes. Required Skills: Good understanding of GDP regulations and ISO 9001 standard, understanding of ISO 13485 advantageous. Proven experience in a quality assurance role, preferably within the distribution or logistics sector. Excellent more »

the continued performance, safety and reliability of our products. We would love to hear from people who are familiar with industry standards such as ISO 13485, IATF 16949 and you can expect to liaise with the Quality team in terms of compliance and continuous improvement. As a detailed more »

the continued performance, safety and reliability of our products. We would love to hear from people who are familiar with industry standards such as ISO 13485, IATF 16949 and you can expect to liaise with the Quality team in terms of compliance and continuous improvement. As a detailed more »

will feed into your constantly evolving test procedure designs. We would love to hear from people who are familiar with industry standards such as ISO 13485, IATF 16949 and you can expect to liaise with the Quality team in terms of compliance and continuous improvement. As a detailed more »

will feed into your constantly evolving test procedure designs. We would love to hear from people who are familiar with industry standards such as ISO 13485, IATF 16949 and you can expect to liaise with the Quality team in terms of compliance and continuous improvement. As a detailed more »

Qualifications: Experience the life sciences or similarly regulated industry (In-vitro Diagnostics preferred) A practical understanding of record audit and material approval processes per ISO 13485:2106 for the Design and Manufacture of In-vitro Diagnostics Experience with an Enterprise Resource Planning System (ERP) Experience with Electronic Document more »

problem-solving skills and ability to work in a collaborative environment. Experience with cloud infrastructure automation tools. Desirable: Familiarity with medical device development standards, ISO 13485: Understanding of quality management systems specific to the medical device industry, ensuring adherence to regulatory requirements and best practices throughout the product … lifecycle. ISO 14971: Knowledge of risk management principles in medical device development, enabling the identification, assessment, and mitigation of potential hazards to patient safety. ISO 62304: Proficiency in software lifecycle processes for medical device software, ensuring the development of safe and effective software that meets regulatory requirements. ‍ Join 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, ISO 13485 Good written and verbal communication skills, and able to work effectively in a busy and 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, ISO 13485 Good written and verbal communication skills, and able to work effectively in a busy and more »

Instructions and Standard Operating Procedures (SOPs). Collaborate with Engineering, Manufacturing, and Biology teams to achieve regulatory submission and product launch. Ensure compliance with ISO 13485/FDA regulatory requirements. Qualifications … To be successful in this role, you should have: Practical experience in verification of In Vitro Diagnostic (IVD) devices or medical devices within an ISO13485/21CFR regulated environment. Experience in writing test protocols aligned with Product Requirement Specifications. A degree in Science or Engineering or equivalent relevant experience. Experience … in medical device development and commercialization. Preferred Skills Hands-on experience in an ISO13485/FDA regulated environment. Strong background in developing and executing verification and validation protocols. Ability to collaborate effectively with cross-functional teams. Apply now as interviews are already being scheduled more »

Instructions and Standard Operating Procedures (SOPs). Collaborate with Engineering, Manufacturing, and Biology teams to achieve regulatory submission and product launch. Ensure compliance with ISO 13485/FDA regulatory requirements. Qualifications … To be successful in this role, you should have: Practical experience in verification of In Vitro Diagnostic (IVD) devices or medical devices within an ISO13485/21CFR regulated environment. Experience in writing test protocols aligned with Product Requirement Specifications. A degree in Science or Engineering or equivalent relevant experience. Experience … in medical device development and commercialization. Preferred Skills Hands-on experience in an ISO13485/FDA regulated environment. Strong background in developing and executing verification and validation protocols. Ability to collaborate effectively with cross-functional teams. Apply now as interviews are already being scheduled 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 »