324 Iso 13485 Jobs - Page 4

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...

Job Description Summary In this role, you will be doing the verification and validation activities for X-ray products, ensuring system-level and sub-system quality and safety. You will be responsible for managing product and system requirements traceability and flow-down, and driving comprehensive validation and verification strategies, including system-level testing. Leveraging deep technical expertise and analytical thinking, you will conduct impact analyses and ensure compliance with safety, quality, and performance standards. Success in this role requires strategic clarity, strong cross-functional collaboration, and the ability to drive verification efforts and across diverse teams and d...

We are currently seeking an Advance Technician Production Operations who will be responsible for supporting in manufacturing day-to-day activities in Dispensing/Packaging/Labeling. Candidate must be able to manage team or supervise their down line to ensure meeting daily output. The company is compliant with ISO 9001: 2015, ISO 13485: 2016 & EN ISO 13485: 2016, MDSAP and Beckman Coulter corporate Quality system requirements. In this role, you will be responsible for: Understand the process for labeling, Dispensing & Packaging and responsible to handle unit operation of Packaging instruments. Responsible to meet the FPY and OTD Targets for production as per planning schedule. Escalation to re...

Key Responsibilities: Define and execute the design and development strategy for renal care devices Lead the complete product development lifecycle from concept to commercialization Ensure compliance with international regulatory and quality standards (ISO 13485, IEC 60601, US FDA, MDR, CDSCO) Build, mentor, and manage a high-performing cross-functional design and development team Collaborate with clinicians, regulatory affairs, manufacturing, and commercial teams to align product design with market and clinical needs Drive innovation in device design, usability, and technology integration Oversee design control processes, technical documentation, and risk management Qualifications & Skills:...

Role & responsibilities Job Title Manufacturing Engineer/Process Validation Engineer Location – Chennai Delivery looking immediate joiner only Conduct detailed gap assessments of current manufacturing practices against applicable medical regulatory standards (e.g., FDA, ISO 13485, EU MDR, GMP). Review process controls, equipment validation, and quality systems documentation to identify non-compliances and areas for improvement. Identify systemic issues and risk areas related to manufacturing quality, process robustness, and compliance. Support remediation activities including process updates, validation efforts, documentation revisions, and training plans. Strong understanding of regulatory ...

Job Title Product Safety & Risk Manager (Software Systems Engineering) Job Description The Product Risk Manager ( with a Software Systems Engineering View) is responsible for overseeing cross-functional teams in risk management activities during product development, ensuring compliance with regulations and standards, managing multiple products, guiding direct reports, conducting inquiries into incidents, driving process improvements, acting as a liaison between departments, and improving risk communication strategies internally and externally. The role orchestrates highly complex process improvement initiatives within workstreams and drives efficiency and innovation through strategic insight...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At HemoCue, one of Danaher's 15+ operating companies, our work saves livesand we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact innovating at the speed of life. HemoCue is a leading provider of point-of-care diagnostic solutions, enabling healthcare practitioners across clinical settings and geographies to improve patient outcomes and clinical workflows. ...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Beckman Coulter Life Sciences, one of Danaher's 15+ operating companies, our work saves livesand we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact innovating at the speed of life. At Beckman Coulter Life Sciences, we know time is the most critical facet in the laboratory today: time to get life-saving therapies to patients faster; reclaiming time by au...

We build cloud platforms to digitize, process and securely store this data. We deploy advanced analytics and machine learning algorithms to draw actionable insights for patient care. We specialize in enabling IoT for wearables and medical devices to gather patient-generated health data. Our expertise in the development of healthcare monitoring devices like glucometers, heart monitors and asthma tools and our proficiency in cloud platforms positions us to design and develop reliable remote monitoring systems. We enable the early detection and real-time monitoring, detection and diagnosis of acute illness, drug intoxication, cardiovascular problems and other health conditions. Leverage our exp...

Service Engineer (Medical Devices) B.Tech/Diploma ECE 2 - 3 Years Bhatinda 19. Service Engineer (Medical Devices) B.Tech/Diploma ECE 2 - 3 Years Amritsar 20. Service Engineer (Medical Devices) B.Tech/Diploma ECE 2 - 3 Years Ranchi 21. Service Engineer Radiology (X-Ray C-Arm) B.Tech/Diploma ECE 2 - 3 Years Delhi 22. Sales Engineer (Medical Devices) B.Tech/Diploma ECE 2 - 3 Years Kerala 23. Sales Engineer (Medical Devices) B.Tech/Diploma ECE 3 - 4 Years Bengaluru 24. Service Engineer (Medical Devices) B.Tech/Diploma ECE 2 - 3 Years Mumbai / Pune 25. Sr. Sales Engineer (Medical Devices) B.Tech/Diploma ECE 4 - 6 Years Jaipur 26. Service Engineer (Medical Devices) B.Tech/Diploma ECE 1 - 3 Years M...

About Us: Advanced MedTech Solutions is a leading innovator and manufacturer of the medical devices, dedicated to improving patient outcomes through advanced healthcare products. We are committed to excellence and continuous improvement in all our operations. Position Overview: This role will oversee a team of design engineers, managing the end-to-end process of product design, development, and improvement. This role combines technical expertise with leadership skills to ensure innovative, compliant, and reliable product solutions. Key Responsibilities: Lead, mentor, and manage a team of design engineers to achieve project milestones and technical excellence. Drive the conceptualization, des...