1 to 25 of 109 ISO 13485 Jobs

Principle Design Engineer Cardiff CF14 £60-65,000 Commutable f rom Cardiff, Newport, Bridgend, Caerphilly, Barry, Llantrisant, Pontypridd Benefits:- Highly competitive salary Bonus Opportunity 25 Days + Bank Holidays Employee assistance programme Matched 5% pension Funded company social events Free more »

similar. Experience in process and product validation (sterile packaging according to ISO 11607 would be advantageous). Understanding of a quality management system (ISO13485/FDA) and medical device manufacturing advantageous. Very good MS-Office skills, especially Excel. Strong organizational skills with the ability to communicate at all levels 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 »

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 »

CAD, and manufacturing design in a regulated setting. Comprehensive knowledge of regulatory standards, including FDA and CE marking for Class III devices. Familiarity with ISO 13485, ISO 14708, and other relevant medical device standards. ✨ What Sets This Role Apart: Collaborate with top minds in an innovative, ethical 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 »

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 »

CAD, and manufacturing design in a regulated setting. Comprehensive knowledge of regulatory standards, including FDA and CE marking for Class III devices. Familiarity with ISO 13485, ISO 14708, and other relevant medical device standards. ✨ What Sets This Role Apart: Collaborate with top minds in an innovative, ethical 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 »

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 »

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 »

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 »

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 »

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 »

to reduce or mitigate any identified risks. Maintain knowledge of site policies and procedures, especially the quality system Develop and maintain working knowledge of ISO13485 & ISO9001, MDD/MDR, GDP, ISO27001 and LSAS requirements. Support regulatory and customer audits when delegated by the QA/RA Manager/Management representative … NC, CAPAs, Change Controls, Document updates, Risk Assessments. Support the internal audits/self inspection schedule and perform audits against cGDP and standards; ISO9001, ISO13485, ISO27001, ISO22301 & LSAS as the schedule dictates and maintain an inspection ready status. Perform local area and local system audits. Training/coaching of operations … a medical device or pharmaceutical quality function Qualified Internal Auditor Desirable: Good knowledge of the requirements of the MDD/MDR as well as ISO13485 & ISO9001 Ability to work in matrix teams. Experience of working with multiple QMS systems Understanding of the requirements of GDPR & ISO27001 Basic knowledge of the more »

for a Quality Manager to join our medical device client in Northamptonshire on a 6 month Fixed Term Contract. Applicants should be experienced with ISO 13485, validation and verification and MDR would be advantageous. Client Details Our client are a regulated manufacturing and distribution company based in the … step into management. Description Key Responsibilities but not limited to: Creation and control of quality documents (SOPs, WIs, records etc) Management Representative responsible for ISO 14385 certification and maintaining the effectiveness of the Full Support Healthcare QMS Maintenance and communication where required of technical documentation Investigate and report on … to be sterilised Verification and Validation of new products and product range extensions.Profile 5+ years' experience in a healthcare quality and regulatory compliance role. ISO 13485 auditor. Working knowledge of ISO 13485, UK and EU MDR. Demonstrable technical writing capability. Excellent attention to detail. Interpersonal and more »

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 »

the ability to implement robust document control processes while working closely with the Head of Quality and Regulatory Affairs establish the QMS aligned with ISO 13485 requirements, driving continuous improvement and operation excellence. The successful candidate will also compile technical files with comprehensive documentation to support regulatory submission … and product certification while conducting risk management activities in accordance with ISO 14971, identifying potential hazards, assessing risks and implementing effective mitigation strategies. Quality and Regulatory Specialist Key Responsibilities: Manage and organize quality and regulatory documentation Ensure timely and accurate filing per industry standards Maintain compliance with regulatory requirements … regulatory affairs within the medical device industry, preferably with exposure to software (IEC 62304) and Software as a Medical Device (SaMD) Strong understanding of ISO 13485, ISO 14971, and other relevant regulatory standards Excellent communication skills with the ability to collaborate effectively across multidisciplinary teams Detail-oriented more »

identification. Conduct quality audits across all organisations. Performance Measures: Maintain documented quality systems across the group. Support internal and external audits for compliance with ISO 13485, UK MDR 2002, MDR 2017/745, MDD 93/42/EEC, MDSAP, and other regulations. Prepare and maintain QMS and … documentation. Assist QA Admin team with product approvals for UK and international markets. Evaluate suppliers and conduct approval audits. Document quality audits to meet ISO, UK, European and worldwide regulatory requirements. Facilitate quality improvement initiatives. Analyse data for management reviews and non-conformances. Conduct CAPA and non-conformance investigations. … Review customer complaints and maintain incident reporting. Meet LSAS objectives and targets. Core Competencies: Experience with BS EN ISO 13485 and global device directives/regulations. Maintain technical/design history files for compliance. Medical experience in a production/manufacturing environment. Internal and external quality auditing experience 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 »

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 »

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 »

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 »

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 »