Rosyth, Scotland, United Kingdom Hybrid / WFH Options
Optos
will feed into your constantly evolving test procedure designs. We would love to hear from people who are familiar with industry standards such as ISO13485, IATF 16949 and you can expect to liaise with the Quality team in terms of compliance and continuous improvement. As a detailed 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 ISO13485 quality management system and collaborate effectively with other engineers to support research and development initiatives and the overall project goal – Better patient 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 ISO13485 quality management system and collaborate effectively with other engineers to support research and development initiatives and the overall project goal Better patient more »
requirements, identify gaps, and apply boundary analysis and other formal techniques to requirements. Knowledge of medical device Quality Management Systems and standards such as ISO13485 or IEC 62304. Experience building medical applications, or applications in domains with similar regulatory constraints. Who you are: Consistently delivers high-quality 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 »
South West London, London, United Kingdom Hybrid / WFH Options
Austin Vita
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 ISO13485 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 »
Basingstoke, England, United Kingdom Hybrid / WFH Options
Blatchford
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 ISO13485 (Desirable) Strong communicator with good interpersonal Highly analytical Able to assess information and data leading to rational judgements and successful conclusions. Ability 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 (ISO13485). If interested, please apply, or reach out for further information about the role 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 (ISO13485). If interested, please apply, or reach out for further information about the role more »
Oxford, Oxfordshire, South East, United Kingdom Hybrid / WFH Options
Orion Electrotech Design
in circuit design, schematic capture, PCB layout, and simulation tools. Experience of version control systems (Altium, PDM etc) Familiarity with regulatory standards such as ISO13485 and IEC 60601 is a bonus but not a deal-breaker. Excellent problem-solving skills and attention to detail. Ability to thrive more »
Oxfordshire, England, United Kingdom Hybrid / WFH Options
Orion Electrotech
in circuit design, schematic capture, PCB layout, and simulation tools. Experience of version control systems (Altium, PDM etc) Familiarity with regulatory standards such as ISO13485 and IEC 60601 is a bonus but not a deal-breaker. Excellent problem-solving skills and attention to detail. Ability to thrive more »
advice according to established procedures relating to CAPA, Complaint, Post Market Surveillance and NCR and against the external requirements of the relevant regulatory authority (ISO13485, Medical Device Directive MDD 93/42/EEC/Medical Device Regulation (EU) 2017/745 and 21 CFR Part 820) and local quality 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 »
accordance 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 to more »
PHD and/or MBA within a relevant Scientific, Quality Management, or Engineering field Expertise and proven working experience with current ISO9001:2015 and ISO13485 standards Industry experience in a Quality role and in a Senior Leadership position (department head) Experience of running a medium-sized Life Science organisation Well more »
are: A background in electronics and/or electro-mechanical assemblies is essential for this role, and experience with Quality management systems such as ISO13485, AS9100 or ISO9001 Electro-mechanical apprenticeship or similar higher education award in this or an associated area e.G., HNC, HND or Level 3 NVQ in 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 »
Experience operating in ISO9001 environment Excellent working knowledge of document management systems, change control and CAPA systems Knowledge and experience of working in an ISO13485 environment is advantageous Good team player and able to work in a fast-paced environment with minimal supervision Keywords: Quality Assurance Specialist, QA Specialist, Regulatory … Specialist, Quality Assurance Manager, QA Manager, ISO9001, ISO13485 Bond Williams Professional Recruitment are an equal opportunity employer and operate as an Employment Business and Recruitment Agency more »
Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
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 ISO13485 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 ISO13485 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 »
functional teams Experience in root cause investigation and analysis of failures to develop corrective and preventative actions Experience working with regulatory requirements, including AS9100, ISO13485, and IATF 16949, is a plus Experience working with suppliers and customers more »
all levels. Non clinical and clinical experience and being able to input into both RA and Clinical. Previous experience working within the requirements of ISO13485, the Medical Devices Directive (93/42/EEC), and/or the IVD Directive (98/79/EC). Lead more »
Forest Row, East Sussex, South East, United Kingdom
Bennett and Game Recruitment LTD
FAIRS. Quality Manager - Part time/Maternity Cover Position Requirements Proven experience with a Quality Management role ISO9001 internal auditing experience A knowledge of ISO13485 standards is desirable but not essential Experience with QMS and ERP systems Based in a commutable distance of Forest Row Quality Manager - Part time/ more »
least one of: electronic devices, embedded software, or application software Proven years direct project management experience Proven record of successful project management within an ISO13485 or similar quality system Proven ability to deliver results through others, both direct and matrixed. Proven ability to build/lead dedicated, passionate teams. Can more »