1 to 25 of 80 ISO 13485 Jobs in the UK

a proven background in In Vitro Diagnostics or Medical Devices. You will have strong experience in the management and/or implementation of an ISO 13485 QMS, CAPA processes and auditing. Key Responsibilities: Develop and Maintain ISO 13485 QMS Support the implementation and transition to an … scientific or technical field Proven experience in the IVD or Medical Device Industries Proven experience in the maintenance and/or implementation of an ISO 13485 QMS Proven experience and knowledge of CAPA Process and Auditing Auditing certification is highly advantageous If you have the necessary skills and more »

primed for you as an individual who is well versed in Quality Engineering within the medical technology sector. Areas such as MDR, MDD and ISO 13485 will be second nature to you as this opportunity will allow you to be the subject matter expert for the business, to … week from home. What will you be doing as their next appointed Quality Systems Engineer? Perform internal quality audits in line with their accreditation (ISO 13485) against work instructions, manufacturing proceedures etc. Maintain and support their Improvement Culture, using your insight and analysis from performing audits as to … with other internal stakeholders on QMS related activities. Ready to apply? This is what you will need to demonstrate; Qualified/Certified Auditor for ISO 13485 (please note, this is a deal breaker for our client) Hands on knowledge of IS0 3485 i.e. you have worked in medical 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, ISO 13485 (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, ISO 13485, IATF 16949. Experience in problem solving and investigation tools such as 8D, CAPA, 5-Whys. Experience in 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 ISO 13485 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 ISO 13485 would be an advantage. Eligibility to become GDP Responsible Person and Responsible Person for Import. Good more »

Working knowledge and experience with a Quality Management System, such as deviations, investigations, CAPA, and customer complaints. · (Desirable) Experience of ISO certified QMS (ISO13485) Knowledge (Essential) In depth understanding of approaches to quality for legal manufactures · (Desirable) Knowledge of quality regulations (such as, ISO 13485, ISO more »

of diagnostic technology! Due to the imminent global release of this product, you will need to adhere to the requirements of medical device regulations – ISO 13485/FDA environments. As the Senior Verification & Validation Engineer, your responsibilities will include: Lead the planning of verification activities for the system … Instrument and test consumable. Ensure tests are designed in alignment with product requirements will full traceability. Adhere to the requirements of working in an ISO 13485/FDA regulated environment. Implement verification and validation test plans and protocols for the system/product, documenting all activities within the … degree or equivalent hands-on experience. Recent and relevant practical experience in verification of In Vitro Diagnostic (IVD) devices or medical devices in an ISO13485/21CFR regulated environment. Experience in writing, editing, or addressing product requirements. Proficiency in both Mechanical and Electrical Engineering disciplines. Track record of submitting regulated more »

to the technical file for regulatory submission of the medical products. Managing project timelines and project team workloads. Generating project documentation in line with ISO 13485 and other medical device regulatory requirements. Working closely with the customer to gather relevant concept information. Work closely with the design team …/or training will be provided to assist carrying out these responsibilities. As a medical device manufacturer, our design and development processes comply with ISO 13485 requirements. This position will require organisational and communication skills (verbal and written), problem solving skills, cross-functional teamwork and the ability to more »

to the technical file for regulatory submission of the medical products. Managing project timelines and project team workloads. Generating project documentation in line with ISO 13485 and other medical device regulatory requirements. Working closely with the customer to gather relevant concept information. Work closely with the design team …/or training will be provided to assist carrying out these responsibilities. As a medical device manufacturer, our design and development processes comply with ISO 13485 requirements. This position will require organisational and communication skills (verbal and written), problem solving skills, cross-functional teamwork and the ability to 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 »

product's requirements. Operating under change management and CAPA systems when in appropriate stages of development. Work in accordance with 21 CFR part 820, ISO 13485, ISO 14971, IVDR, and other applicable regulations. Knowledge of IEC 62304 would also be advantageous. Ensure the executive team is kept more »

Experience/Qualifications : Experience within the medical device industry, with knowledge of MDD 93/42/EEC, EU MDR (2017/745) and ISO 13485 is desirable Experience working with technical documentation and data management Experience working on multiple projects simultaneously Key Skills: Excellent technical reading comprehension … Assurance, Quality Assurance Coordinator, QA Coordinator, Health and Safety Officer, Audit, Medical Compliance, MDD 93/42/EEC, EU MDR (2017/745) ISO 13485 etc REF more »

industry. - Familiarity with ISO 9001, ISO 13485, 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 »

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; ISO 13485 & FDA guidelines CFR 21. Senior Hardware Design Engineer Position Requirements Minimum of more »

as part of EMC testing when required. The candidate requires excellent written and verbal communication skills to document their activities in line with the ISO13485 Quality Management System, planning and reporting on their work to a standard suitable for review by regulatory authorities. Skills, Experience & Qualifications: Proven track record in … implementation, and validation of electronics for medical devices or other complex high integrity products. Proven track record of electronics design and development compliant with ISO 13485 and ISO 14971. Familiarity with the regulatory requirements for electrical safety for compliance with European, Canadian and United States quality standards … with practical working knowledge of IEC 60601 and ISO 13485. Experience of version control systems (Altium, PDM) for electronics design highly desirable. Ability to produce Technical Reports to a high standard both in terms of technical content, presentation and written English Enthusiasm, good communication skills and ability to work more »

5+ years’ industry experience. Desirable: Previously involved in the development of wellness and/or medical devices. Experience coding to MISRA standards. Experience writing ISO 62304-compliant software (class A) under an ISO 13485 quality management system. Good understanding of wireless protocols, particularly Wi-Fi and Bluetooth. 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 »

particularly for development activities (change control, version management, documentation, testing, deployment, issue tracking etc.) Assisting with implementation of our quality systems and under the ISO 9001 framework Qualifications, Skills and Abilities Essential Experience in Embedded C Experience in Linux development for embedded systems Familiar with use of real-time … release management. Desirable Experience with digital electronics Experience with REST, JSON, protobuf Some experience with IoT technologies Developing firmware for medical devices Knowledge of ISO 13485 or IEC 62304 Closing Date: Sunday 26th May, 2024 IT-IS is committed to encouraging equality, diversity and inclusion among our workforce. more »

experience: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 verificationProficiency in C/C++ programming languages.Experience with Real-Time Operating Systems (RTOS) and bare-metal development.A demonstrated track 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 »

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 »

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 »

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 »

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 »