1 to 25 of 25 ISO 13485 Jobs with Hybrid or WFH Options

You’ll be responsible for supporting the compliance team to ensure all required certification is maintained. Complete internal audits in compliance with relevant standards (ISO 13485, 21 CFR, MDD/MDR and UKCA regulations) Assist in the logging, investigating, and documenting of all non-conformities Corrective and Preventative … someone with the following skills and experience; Ample experience in Quality Assurance specifically within medical devices Good knowledge of MDR is desired Knowledge of ISO 13485, ISO 9001 and knowledge of ISO 14001 is desirable Experience of Internal Audit, ideally as a lead auditor (desired) Experience more »

ensuring timely delivery, effective resource allocation, and successful project outcomes. Global Perspective. Useful Qualifications/skills/experience Experience in a medical device company ISO 9001 ISO 13485 ISO 60601-1 ISO 14971 EU MDR FDA Medical Devices Why join us? Here at Smartbox, we 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 »

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 »

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 »

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 »

will feed into your constantly evolving test procedure designs. 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 »

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 »

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 »

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 ISO 13485 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 »

Surveillance requirements Using Salesforce Functional knowledge of Quality, Regulatory Compliance, and operations systems and processes to include GMP and QSR requirements for medical devices. (ISO 13485, FDA's QSRs, EU's MDD, Canadian Regulations) is required. Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive more »

Surveillance requirements Using Salesforce Functional knowledge of Quality, Regulatory Compliance, and operations systems and processes to include GMP and QSR requirements for medical devices. (ISO 13485, FDA's QSRs, EU's MDD, Canadian Regulations) is required. Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive more »

Surveillance requirements Using Salesforce Functional knowledge of Quality, Regulatory Compliance, and operations systems and processes to include GMP and QSR requirements for medical devices. (ISO 13485, FDA's QSRs, EU's MDD, Canadian Regulations) is required. Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive more »

Surveillance requirements Using Salesforce Functional knowledge of Quality, Regulatory Compliance, and operations systems and processes to include GMP and QSR requirements for medical devices. (ISO 13485, FDA's QSRs, EU's MDD, Canadian Regulations) is required. Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive more »

Surveillance requirements Using Salesforce Functional knowledge of Quality, Regulatory Compliance, and operations systems and processes to include GMP and QSR requirements for medical devices. (ISO 13485, FDA's QSRs, EU's MDD, Canadian Regulations) is required. Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive more »

Surveillance requirements Using Salesforce Functional knowledge of Quality, Regulatory Compliance, and operations systems and processes to include GMP and QSR requirements for medical devices. (ISO 13485, FDA's QSRs, EU's MDD, Canadian Regulations) is required. Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive more »

Surveillance requirements Using Salesforce Functional knowledge of Quality, Regulatory Compliance, and operations systems and processes to include GMP and QSR requirements for medical devices. (ISO 13485, FDA's QSRs, EU's MDD, Canadian Regulations) is required. Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive more »

Surveillance requirements Using Salesforce Functional knowledge of Quality, Regulatory Compliance, and operations systems and processes to include GMP and QSR requirements for medical devices. (ISO 13485, FDA's QSRs, EU's MDD, Canadian Regulations) is required. Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive 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 »

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 »

into the pharmaceutical market About Us: We are a specialized consultancy providing Regulatory Affairs support to the medical device industry. Our expertise spans across ISO 13485, European regulations, FDA regulations, and other global standards for medical devices. Join our team and be part of a growing consultancy where more »

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 Eng... 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 »

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 »

intent and operational workflow of designed electronic systems to product engineering staff. It would also be great if you have experience of working with ISO13485 and FDA Medical Device Design Control processes. From an educational perspective, you will be degree qualified in electronic engineering or a related field. Life at … analysis using modelling (Cadence and Xilinx) and experimental/prototyping methods Experience in DFx (design for manufacturing, assembly and test) Knowledge and appreciation of ISO13485 and FDA Medical Device Design Control Mentoring/leadership experience or strong potential/natural next step What next? We believe the key to unlocking more »