51 to 75 of 119 ISO 13485 Jobs

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 »

ll also develop prototype algorithmic functions based on data analysis and experimental findings. Additionally, you'll play a role in maintaining adherence to the ISO 13485 quality management system and collaborate effectively with other engineers to support research and development initiatives and the overall project goal Better patient more »

improvement, contributing to continuous improvement initiatives. Qualifications, Skills and Abilities Essential: HND/Graduate level or previous experience in Quality Assurance role Understanding of ISO13485, ISO15189 or ISO9001 requirements Previous experience working with In Vitro Devices (IVD/IVDR) or Medical Devices (MDD/MDR) Attention to detail/concern more »

assigned by supervisor. KNOWLEDGE, SKILLS, ABILITITES: Knowledge of medical device quality system regulations and standards (eg, U.S. FDA Quality System Regulation 21CFR Part 820, ISO13485, ISO9001) Communicates well with required project contacts, seeks to communicate, and form relationships with non-required contacts. Experience with all of the product development life more »

activities and working to develop a capable and robust/stable process. Adhere to Quality Management System (QMS) requirements in line with Corin’s ISO13485 QMS & Good Manufacturing Practice (GMP) FDA21 CFR Part 820. Support brainstorming and problem-solving as required activities for inspection processes and assist in resolving engineering more »

assigned by supervisor. KNOWLEDGE, SKILLS, ABILITITES: Knowledge of medical device quality system regulations and standards (eg, U.S. FDA Quality System Regulation 21CFR Part 820, ISO13485, ISO9001) Communicates well with required project contacts, seeks to communicate, and form relationships with non-required contacts. Experience with all of the product development life more »

development, implementation, and continual improvement of an efficient and effective Quality Management System (QMS). Responsibilities include: * Plan and conduct internal quality audits (EN ISO 13485:2016) in accordance with the audit schedule and company procedures and work instructions (QA-SOP-019 – Quality and Environmental Audit Management), ensuring … and implement process improvements in conjunction with Line Managers/Process Owners to ensure processes required for the QMS meet the requirements of relevant ISO standards and applicable regulatory requirements. THE PERSON In order to succeed in the role of Quality Systems Engineer you will require experience of working more »

organisation whilst assisting meeting our regulatory responsibilities. Key duties: Implementation, maintenance, continuous improvement, and support of Blatchford’s Quality Management Systems (in line with ISO13485:2016) and the Medical Device Regulations). Collaboration across internal departments to provide Quality Assurance support. Participation in external Quality audit activities. Representing QA for … qualified or equivalent experience in similar role Internal audit qualification Demonstrated experience in a Quality Assurance role, which includes auditing. Good working knowledge of ISO 13485 (Desirable) Strong communicator with good interpersonal Highly analytical Able to assess information and data leading to rational judgements and successful conclusions. Ability more »

in circuit design, schematic capture, PCB layout, and simulation tools. Experience of version control systems (Altium, PDM etc) Familiarity with regulatory standards such as ISO 13485 and IEC 60601 is a bonus but not a deal-breaker. Excellent problem-solving skills and attention to detail. Ability to thrive more »

in circuit design, schematic capture, PCB layout, and simulation tools. Experience of version control systems (Altium, PDM etc) Familiarity with regulatory standards such as ISO 13485 and IEC 60601 is a bonus but not a deal-breaker. Excellent problem-solving skills and attention to detail. Ability to thrive more »

electromechanical medical devices • Excellent understanding of design controls and good documentation practices • Experience in applying regulatory standards to products (IEC 60601, 14971, 62366, 62304, ISO 13485 or aerospace equivalents) • Willingness to be on-site (minimum 2 -3 days/week in London office) Nice to Haves • Experience with more »

Qualifications: Demonstrated experience in the design and development of products - Medical industry advantageous Design or Engineering Degree preferred Familiarity with regulatory standards and QMS - ISO13485 advantageous CAD proficient, preferably Solidworks Plastic manufacturing process knowledge If you want to be part of a team dedicated to making a meaningful impact in 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 »

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 »

developing automated testing and data collection. • Knowledge of medical device quality system regulations and standards (eg, U.S. FDA Quality System Regulation 21CFR Part 820, ISO13485, ISO9001) EDUCATION AND EXPERIENCE: What is the usual educational background and work experience of an individual qualified to perform this job? • B.S. degree in Electronics more »

and attention to detail Working knowledge of ISO9000/IATF16949 – a plus would be experience in a strong compliance industry such as AS9100 or ISO13485 Internal Auditor qualified or lead auditor preferred against ISO9000/IATF16949 Past experience in a similar role is key Previous experience in the semiconductor industry more »

maintenance and control of on-going (or future) compliance to all certifications and standards relevant to the company. These will include as a minimum: ISO13485 (including EU MDR and UK MDR). Fully support the pack assembly team within the production environment and the custom pack team with set up more »

. Collaborate with the Engineering, Manufacturing and Biology teams working towards regulatory submission and product launch. Adhere to the requirements of working in an ISO 13485/FDA regulated environment. Experience … and skills required to be successful in this position: Practical experience in verification of In Vitro Diagnostic (IVD) devices or medical devices in an ISO13485/21CFR regulated environment. Previous experience in writing test protocols in line with Product Requirement Specifications. Degree in Science or Engineering or possess equivalent relevant more »

reliability, and safety of medical devices throughout the development lifecycle. - Support the development of risk management documentation, in accordance with regulatory requirements such as ISO13485 and FDA guidelines. Qualifications: - Bachelor's degree in Engineering, Computer Science, or related field. Master's degree preferred. - Proven experience in systems engineering within the … medical device industry, including knowledge of regulatory requirements such as ISO 13485 and FDA guidelines. - Strong understanding of systems engineering principles, including requirements analysis, system design, integration, testing, and validation. - Excellent communication skills with the ability to collaborate effectively with cross-functional teams and stakeholders. - Experience with risk more »

departments here at the RJAH Orthopaedic Hospital Foundation Trust. The successful candidate will be a dynamic individual who ideally has some prior experience of ISO standards, either in their routine management or implementation within a field, but not necessarily healthcare. This role supports the ongoing maintenance of ORLAU's … existing Quality Management System which underpins its compliance with international quality standards to ISO 13485 and 9001 for both its clinical and technical services. Achievement of these complex standards allows ORLAU to fulfil the requirements of the UK Medical Devices Regulations so that our range of medical devices more »

expanding the molecular products portfolio. The position holder will lead the technical development of new molecular reagents and associated methodologies, while working according to ISO 13485 standards. The role may provide on a project need basis supervision for other team members, planning and coordinating various experimental work and … reagents, including PCR, isothermal amplification, and Next Generation Sequencing applications. Establish and disseminate technical knowledge and good laboratory practices in the group. Work to ISO13485 standards and understand their requirements. Independent planning, execution and troubleshooting of experiments. Write literature to support product launches. Keep accurate laboratory records. Assist with customers more »

report Skills and experience required: + Degree in relevant discipline + Proven experience in medical device development + Previously worked to relevant quality standards – ISO 13485 + Experience in prototyping and testing + Strong 3D CAD skills + Experience in different manufacturing processes - injection moulding The salary will more »

s degree in relevant engineering discipline. Good communication and presentation skills 5 years experience (Min) in medical devices design and development with understanding of ISO 13485 and IEC 60601 design control standards Multi-disciplinary engineering background (e.g., mechanics, electronics, software, data analysis and processing) with a generalist view more »

s degree in relevant engineering discipline. Good communication and presentation skills 5 years experience (Min) in medical devices design and development with understanding of ISO 13485 and IEC 60601 design control standards Multi-disciplinary engineering background (e.g., mechanics, electronics, software, data analysis and processing) with a generalist view more »

s degree in relevant engineering discipline. Good communication and presentation skills 5 years experience (Min) in medical devices design and development with understanding of ISO 13485 and IEC 60601 design control standards Multi-disciplinary engineering background (e.g., mechanics, electronics, software, data analysis and processing) with a generalist view more »