26 to 50 of 72 Permanent ISO 13485 Jobs in the UK

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 »

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 »

you also have experience managing a small team of Quality Engineers, please read on! Main tasks and area of expertise: Maintaining the MDSAP and ISO 13485-certified Quality Management System. Ensure all procedures are up to date with changing standards and regulations and are being implemented by all … employees. Supporting the management of the Information Security Management System alongside the Information Security Officer (as per ISO 27001). Facilitate management reviews, notified body audits, supplier audits, and internal audits. Essential Prior experience of working for a small to medium-sized medical device company in quality or compliance … medical device regulations). External and internal audit experience, including hosting notified body audits, and conducting supplier quality assessments. Knowledge of quality standards including ISO 13485 and ISO 14971 Advantageous Qualification in regulatory affairs or quality assurance Knowledge of MDSAP regulations If this sound like a good more »

Quality related regulations and standards Essential: ISO 9001, ISO 13485, GCP, Desirable: ISO 21CFR Part 820, ISO17025, Clinical Trials experience, ISO13485 Lead auditor (external audits more »

development to launch and maintenance. Manage the engineering budget to achieve product goals. Implement a robust software development process compliant with medical device regulations (ISO 13485, ISO-IEC 62304). Champion information security (ISO 27001) through design, penetration testing, and secure coding practices. Lead product management 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 »

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 »

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 »

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 »

the company's quality management system (QMS) to ensure compliance with regulatory requirements, including training and audits. Support in 3rd party audits according to ISO 13485 and QMSR requirements. Skills and Qualifications: Bachelor's degree in degree in a relevant scientific or engineering field; advanced degree preferred (e.g. more »

to tight deadlines and be able to manage your own time well. It would also be great if you have experience of working with ISO13485 and FDA Medical Device Design Control processes. Life at Optos is fast-paced and everyone tends to chip in. We have an experienced team who more »

products and design new ones Lead presentations and liaise with senior management on a daily basis Have a good understanding of IEC60601 family standards, ISO13485, ISO14971 and BSEN62304 This is a highly varied, challenging and interesting role with an employer of choice in Caerphilly. Not only will you benefit from more »

to control other medical devices. Familiarity with FDA/MDR/UK MDR medical device software regulation is essential including applicable standards such as ISO 13485, ISO 14971, IEC 62304, IEC 82304, and IEC 62366. Deep understanding of software development lifecycle (SDLC) and best practices in the 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 »

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 »

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 »

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 »

functional teams Experience in root cause investigation and analysis of failures to develop corrective and preventative actions Experience working with regulatory requirements, including AS9100, ISO 13485, and IATF 16949, is a plus Experience working with suppliers and customers more »

Ideally, the Medical Devices company you have worked for has produced handheld or portable Medical Devices, but as long as the device is to ISO 13485 standards, we will consider your allocation. You will be rewarded with an excellent starting salary and package while being a part of 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 … orientated qualification Minimum of 3 years experience working in a QA/QS environment, preferably within the medical device or pharmaceutical industry. Knowledge of ISO13485:2003 and Medical Device Directive MDD 93/42/EEC Knowledge of FDA QSR Part 820 Computer literate to include MS Word, Excel and more »

Engineering) or equivalent (e.g Pharma, Biopharm, Life Science, Biotech) Good Experience in Quality Assurance; Problem Solving, Analytical and Continual Improvements. Certified Lead Auditor in ISO 9001:2015 or 13485:2015 Proven background leading and managing teams working with minimum supervision under pressure to tight deadlines with customer focus. 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 »

CD methodologies Excellent problem-solving and communication skills Ability to work collaboratively in a fast-paced startup environment Desirable: Knowledge of or experience with ISO 13485 ISO 14971 Signal Processing ‍ Benefits: Competitive salary and equity options Flexible work arrangements Comprehensive health insurance Professional development opportunities Opportunity to 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 »

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 »