309 Iso 13485 Jobs - Page 3

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Responsibilities may include the following and other duties may be assigned. Lead and mentor cross-functional teams to develop comprehensive signal evaluation reports, product risk management files including risk management plans, Hazard Analysis, DFMEA, and risk management reports, adhering to ISO 14971 standards. Oversee the preparation and compilation of product post-market data and findings into comprehensive Periodic Safety Update...

JD for System Engineer provided by Philips team Primary Skills: typically 5+ Years of experience Bachelor's degree in Electronics or Electronics and Telecommunication. Experience: As a system engineer or in a similar role, with a strong understanding of system architecture and integration. Understanding and awareness of ISO 13485 and ISO 14971 standards, as well as CE certification and knowledge of FDA audits will be beneficial. Technical Skills: Proficiency in system design and development principles. Experience with various medical systems and system software, along with knowledge of LCM and NPI processes. Experience with X-ray systems will be beneficial. Problem-Solving: Strong analytical...

Evaluate and improve Design History Files (DHFs) to ensure compliance with regulatory requirements, identifying gaps and implementing corrective actions. Conduct detailed audits and assessments of existing DHFs to identify non-conformances and areas for improvement, ensuring alignment with current regulations and standards, such as FDA and ISO 13485. Ensure completeness, accuracy, and accessibility of all DHF documentation, including design controls, specifications, verification and validation reports, and risk management files. Collaborate with R&D, Quality Assurance, Regulatory Affairs, and other relevant teams to gather necessary information for DHF updates and improvements, facilitating ...

About the Role: We are seeking a highly skilled and detail-oriented Test Engineer with a strong background in medical technology (MedTech) and Artificial Intelligence (AI) to join our dynamic team. This role is critical in ensuring the safety, reliability, and compliance of AI-powered medical devices and Software as a Medical Device (SaMD) solutions. Key Responsibilities: Understand and evaluate the usage of AI/ML models in medical devices, including algorithm behavior, data integrity, and performance under various clinical scenarios Design and execute comprehensive white-box and black-box testing strategies for embedded systems, cloud-based platforms, and AI components Apply knowledge of Sa...

Setting up, calibration, maintenance, sterilization of laboratory equipment, and maintain masterlist for all BEC Dx instruments. Record all experimental data and test results in the required electronic templates and formats Handle samples, Testing and maintaining the BEC Dx instruments The essential requirements of the job include: A Bachelors in a relevant scientific field, such as Engineering, Biomedical or Medical Laboratory Technology 3+ years of experience managing the lab operations for R&D projects Proven experience in diagnostic or IVD laboratory setting, or relevant specialized labs. Experience in operating diverse electrical and non-electrical laboratory equipment and safely handli...

Department : Product, Data and AI Engineering About the Role: We are seeking a highly skilled and detail-oriented Test Engineer with a strong background in medical technology (MedTech) and Artificial Intelligence (AI) to join our dynamic team. This role is critical in ensuring the safety, reliability, and compliance of AI-powered medical devices and Software as a Medical Device (SaMD) solutions. Key Responsibilities: Understand and evaluate the usage of AI/ML models in medical devices, including algorithm behavior, data integrity, and performance under various clinical scenarios. Design and execute comprehensive white-box and black-box testing strategies for embedded systems, cloud-based pla...

Job Title: Manufacturing Engineer Medical Devices (Senior/Principal Level)(Remote) Location: Hyderabad, IND Employment Type: Part-time Position Summary: We are seeking an experienced Manufacturing Engineer Trainer with 10-15+ years of hands-on expertise in the medical device industry to support and enhance our manufacturing operations. The ideal candidate will have a proven track record in process development, validation, scale-up, and continuous improvement while ensuring compliance with FDA, ISO 13485, and GMP regulations . Key Responsibilities: Lead the design, development, and optimization of manufacturing processes for Class II/III medical devices. Drive process validation activities, i...

Roles And Responsibilities Lead and manage CAPA process from initiation to closure. Coordinate root cause investigations and ensure robust corrective actions. Track and report CAPA metrics and trends to management. Drive quality improvement projects and cross-functional collaboration. Ensure timely documentation and regulatory compliance. Facilitate audits and provide CAPA-related evidence. Support risk management and preventive action initiatives. Qualifications Bachelor's degree in Engineering, Mechanical or related field. 7+ years experience in Quality/Regulatory in the medical device industry. Strong knowledge of ISO 13485, 21 CFR 820, EU MDR, and risk management (ISO 14971). Project man...

We invite applications from suitable candidates from the engineering industry, preferably with experience in the machine building, material handling, process equipment & automotive sectors. Professionals from the Health, IT, Civil construction, Financial services, Oil & Gas sectors will not be a good fit. The intention is to find a capable engineering intrapreneur; a CEO with BS/P&L responsibility to manage the operations of the Company ABOUT THE JOB This job is for a CEO intrapreneur; an inside entrepreneur; an entrepreneur within an established Company, who uses entrepreneurial skills to manage, develop and grow the Company. This job is about taking over the management function from the fo...

Role & responsibilities 1. Product Registration & Certification - Support in preparing the documentation or dossier as applicable for the product registration and the certifications. - Update the documents, for response to queries and other requirements as required by respective regulatory authorities in a stipulated time frame. 2. Regulatory Audits -Internal and External Audit - Provide assistance in Internal & External audits. - Draft, Internal audit reports and coordinate with auditors for the closure of audits in a timely manner - Assist with follow-up audits, as required. 3. QMS-Maintenance - Compile and maintain regulatory documentation databases as per ISO 13485:2016 and other applica...

Job Description Summary Performs a variety of quality assurance activities to ensure successful completion of projects or aspects of large programs. Applies technical expertise and knowledge of advanced statistical techniques to support engineering work in the design, development, and evaluation of medical devices. Supports development and successful implementation of quality systems and procedures. Supports maintenance and expansion of QMS as required. Works under general direction while independently determining and developing approaches to solutions. Frequent inter-organization contacts to achieve stated objectives. Job Description Educational Background Bachelor's degree in mechanical en...

We are also Considering candidates Willing to Relocate - Job Location : Chennai Embedded Firmware Architect | Medical Devices | IEC 62304, IEC 60601 | Experience : 15 - 25 Years We are accepting Job Applications : Please submit updated CV - Email : [HIDDEN TEXT];[HIDDEN TEXT] Embedded Firmware Architect | Medical Devices | IEC 62304, IEC 60601 | Senior / Firmware Architect - Medical Devices | 10 - 20 Years | Job Description Responsibilities include - Design and architect embedded software systems from concept to production. - Lead and mentor a team of embedded software engineers. - Develop and maintain embedded software architectures and design patterns. - Optimize software for performance, ...

Company Description Elesonic Group, originally founded in 1965, has grown substantially since establishing its in-house X-ray machine manufacturing plant in 2006. Elesonic Healthcare Private Limited, based on the outskirts of Kolkata with a National Sales office in Central Kolkata, specializes in manufacturing medical equipment like X-ray and C-arm machines. By 2019, Elesonic expanded its operations to African Union through offices at Nigeria and Uganda. Same Year in 2019 Elesonic established a presence in Canada for Trans atlantic operation including Carribean Islands. Our pledge is to deliver quality and exceptional service in the industry. Join us in making the world a healthier place! Ro...

Responsibilities : Skills: Good knowledge of CMMI Model, ISO 9001 standard, ITIL practices, Distributed Agile methodologies, DevSecOps models Hands-on experience in practicing and implementing Agile and DevOps practices in both Development and Service/Support projects Hands on experience in handling/supporting few accounts or programs Strong Analytical, Inter-Personal, Networking and Presentation Skills Ability to coordinate with Senior Stakeholders from Delivery and Quality Ability to extract process deficiencies based on factual data Strong Communication and Articulation Skills (Oral & Written) Preferred: PMP, ITIL, CSPO, CSM, DevOps Certifications, Certified SAFe Agilist 5.0 Roles & Respo...

Why join AliveCor ? At AliveCor, we imagine a healthier world powered by access to personalised intelligent information. Were on a mission to be the world s heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical ECG devices and continues to lead the way in empowering consumers and patients to take care of their heart. Using our FDA-cleared medical-grade hardware and software, millions of users have taken more than 200 million heart health measurements and counting. Our vibrant team of people are attracted to AliveCor because they want to build something meaningful -- and AliveCor delivers: every day, customers tell us that ...

Job Description: Role Senior Audit Program Manager Experience 8 years of experience Qualification B E Computer Science or Information Technology Engineer Professional Competencies Mandatory ISO Standards CMMI High Maturity Practices Agile DevOps ISO 9001 ITSM CSM DevOps and relevant Industry Certifications around these competencies Preferred CMMI ISO 13485 AS9100D ISO 42001 in addition to above Mandatory Skills PMP Prince 2 CSPO Certified SAFe Agilist 5 0 Certifications can also apply Key Responsibilities: Skills Good knowledge of CMMI Model ISO 9001 standard ITIL practices Distributed Agile methodologies DevSecOps models Hands on experience in practicing and implementing Agile and DevOps pr...

About the Role: OptraSCAN is advancing precision diagnostics through digital pathology. As Quality Assurance, you will support the integrity and effectiveness of the Quality Management System (QMS) across our Digital Pathology Systems and Software as a Medical Device (SaMD) portfolio. You will contribute to compliance with ISO 13485:2016, 21 CFR 820, EU IVDR, MDSAP, and Indian Medical Device Rules 2017, working across design, manufacturing, and post-market activities. This role collaborates with R&D, Regulatory Affairs, Manufacturing, Supply Chain, and Commercial teams. Core skills: Assist in maintaining and updating QMS documentation (SOPs, Work Instructions, Records). Help coordinate inter...

Opportunity to work with a global medical equipment company Opportunity to take on a leadership role and contribute to the company's vision About Our Client Our client is a leading global medical technology company that provides innovative solutions in diagnostic and therapeutic imaging, laboratory diagnostics, and digital health services. Job Description The Successful Applicant Regulatory Strategy Development Define and drive the regulatory vision and strategy for CRM products, aligning with Healthineers business goals. Establish a roadmap for regulatory submissions, approvals, and compliance for new and existing product lines. Lead initiatives to address regulatory challenges in emerging ...

Job Description Summary Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). Developing conceptual knowledge of professional discipline. May include support roles with specialized expertise or technical knowledge in broad area. Job Description Roles and Responsibilities Creates a Quality culture by driving compliance activities around a specific product, site or region. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Broadening knowledge of theories, practices and procedures in own discipline to...

Job Opportunity: Production Engineer (IVD RT-PCR Medical Devices) About the Role We are looking for an experienced Production Engineer to join our team in the In Vitro Diagnostics (IVD) sector. This role involves managing daily production activities for RT-PCR medical devices, ensuring compliance with ISO 13485 and GMP standards, and driving efficiency, quality, and continuous improvement within the production process. Key Responsibilities Execute and monitor daily production activities for IVD RT-PCR medical device manufacturing. Ensure adherence to ISO 13485 and GMP guidelines throughout the production process. Operate and maintain critical production equipment. Coordinate with planning an...

Job Opportunity: Production Engineer (IVD RT-PCR Medical Devices) About the Role We are looking for an experienced Production Engineer to join our team in the In Vitro Diagnostics (IVD) sector. This role involves managing daily production activities for RT-PCR medical devices, ensuring compliance with ISO 13485 and GMP standards, and driving efficiency, quality, and continuous improvement within the production process. Key Responsibilities Execute and monitor daily production activities for IVD RT-PCR medical device manufacturing. Ensure adherence to ISO 13485 and GMP guidelines throughout the production process. Operate and maintain critical production equipment. Coordinate with planning an...

Bachelor's degree in a related field (e.g., Mechanical Engineering, Bio Medical) 8-10 years of work and project management experience, Leading or supporting the execution of Small to large-scale sustenance engineering projects like FCO (Field Change Orders) projects Strong Knowledge on ISO 13485, ISO 14971 and FDA- 21CFR 7, 21CFR 810 & 21CFR 806 Ensures to comply with QSR, ISO and Environment, HS requirements, as well as all applicable company procedures and policies Interacts and collaborates with other departments to solve any restriction that may stop or slow down process issues. Cross-Functional Collaboration: Facilitate cross-functional collaboration for remediation plan implementation,...

Technical Product Owner Medical Device Software We are seeking a Technical Product Owner (TPO) to lead the definition, prioritization, and delivery of software features for next-generation medical device platforms. This role acts as the key bridge between product management, engineering, quality, and regulatory teams ensuring software solutions align with clinical needs, regulatory standards, and business goals. Key Responsibilities: Manage and own the software product backlog for medical device components. Translate complex clinical, business, and user needs into clear user stories, requirements, and specifications. Collaborate with cross-functional teams (engineering, QA, UX, regulatory, a...

As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory s role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making we are enabling clinic...

This role is part of R&D (Research & Development) focusing on Software Verification & Validation (V&V) for healthcare/medical/pharma-related systems. Key Responsibilities Perform software verification & validation to ensure compliance with medical device/healthcare software standards. Develop, execute, and automate test cases, scripts, and frameworks. Work on test planning, defect tracking, debugging, and quality assurance activities. Collaborate with cross-functional teams R&D, product engineering, and regulatory teams. Ensure compliance with ISO 13485, IEC 62304, FDA guidelines (typical in medical software). Skills & Requirements Strong background in manual + automation testing for softwar...