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 »
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 »
laboratory sector. The products are supported with a full range of laboratory services as well as comprehensive servicing and repair capability. The company is ISO13485 certified. We have an excellent opportunity in our Services Team for a Service engineer who is looking to build on their experience to date working … the ability to respond to emergencies. Experience of maintenance repairs, such as electrical, and plumbing. To have an understanding of Quality Standards such as ISO13485, ISO9001, ISO14001 or other applicable standards, working with a Quality Management System. Ability to work independently and manage time effectively. Maintain accurate records of maintenance more »
support the Head of QA, responsible person and responsible personfor import, in the implementation and maintenance of the Quality Management System in accordance with ISO 9001 and ISO13485 standards, and in compliance with EU GDP guidelines. Ideally you will have experience of working in a GMDP … to urgently and accurately perform all operations required during a pharmaceutical recall. Key Skills/Experience/Requirements: Good knowledge of GDP and the ISO 9001 standard, understanding of ISO13485 would be an advantage. Eligibility to become GDP Responsible Person and Responsible Person for Import. Good more »
concepts to diverse audiences. Strong knowledge of regulatory requirements and quality standards applicable to medical device development and manufacturing, such as FDA regulations and ISO 13485. Our Benefits: 26 days' holiday with the option to buy or sell an additional 5 Up to 10% employer pension contribution Share and 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 »
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 »
Petersfield, Hampshire, South East, United Kingdom
Bennett and Game Recruitment LTD
including creating and implementing test plans. Maintain an appropriate working knowledge of medical standards including but not limited to IEC 60601-1 Ed 3; ISO 14971; IEC 62366; ISO 62304; ISO13485 & FDA guidelines CFR 21. Senior Hardware Design Engineer Position Requirements Minimum of more »
and developing a positive Quality culture within the organisation. Supporting all other departments to ensure they remain compliant to the accreditations. Primarily, the AS9100, ISO 9001, ISO13485 (Medical Devices) accreditations for the Company and such other schemes or programs which arise through Customer or market needs … equivalent. Experience (minimum 2 years) in a quality position within a manufacturing/engineering environment. Experience working within one of the following regulated industries: ISO 9001, AS 9100, ISO13485, IATF 16949. Experience in problem solving and investigation tools such as 8D, CAPA, 5-Whys. Experience in more »
product's requirements. Operating under change management and CAPA systems when in appropriate stages of development. Work in accordance with 21 CFR part 820, ISO13485, ISO 14971, IVDR, and other applicable regulations. Knowledge of IEC 62304 would also be advantageous. Ensure the executive team is kept 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 »
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 »
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 »
performance and accuracy of medical technologies.Algorithm Development- Develop prototype algorithmic functions based on data analysis and experimental findings.Quality Assurance: Assist in maintaining adherence to ISO13485 standards and contribute to quality control processes. To be successful in this position you will need:Bachelor's or Master's degree more »
a relevant scientific discipline. Significant (>3 years) relevant technical experience. Nucleic acid assay development experience. Commercial IVD product development experience. Quality Management & Regulatory frameworks, ISO13485, FDA 21 CFR 820 and cGMP. Previous line management experience. Strong laboratory-based background. Attention to detail and well organized. Please share more »
Would you like to be part of a team helping to create something truly ground-breaking and game changing in the medical device industry? We have a world class diagnostic technology that enables rapid detection of respiratory viruses such as 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 ISO13485/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 ISO13485 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 »
industry. - Familiarity with ISO 9001, ISO13485, GCP is essential. - Knowledge of ISO 21CFR Part 820, ISO17025, Clinical Trials experience, ISO13485 Lead auditor would be beneficial. Interested or know someone who might be? Reach out to Ben Godley using the following: ✉️ 📞 01892 362010 Apply now: If 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 »
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 »
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 »
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 »
vast quantities of raw data Experience with Python, including libraries such as NumPy, SciPy, Pandas etc. Any Medical Device Software experience and understanding of ISO13485 would really set your application apart! What Next? If you’re a Data Analyst/Data Scientist looking to work on a more »
Proven success in leading Medical Device Class IIa or above products through the MDR process. Strong knowledge of European regulatory requirements and standards (MDR, ISO13485, etc.). Experience managing a regulatory affairs team is desirable. Excellent communication and interpersonal skills, with the ability to interact effectively with more »