215 Iso 13485 Jobs - Page 4

Skills: Ensure QMS compliance with ISO 13485:2016, ZED, and GMP standards. Review and approve batch records, SOPs, and quality documents. Oversee product packaging, labeling, testing, and release for dispatch. Investigate and manage deviations, complaints, CAPAs, and change controls. Monitor warehouse conditions, equipment calibrations, and validation records. Coordinate internal/external audits, inspections, and supplier evaluations. Ensure timely product testing and maintain ETO batch records. Conduct training sessions on quality procedures as per schedule. Prepare Certificates of Analysis and assist in regulatory certifications. Coordinate with cross-functional teams for QMS adherence and...

A Day in the Life Collaborating with cross-functional teams to develop comprehensive product risk management files, including the risk management plan, Hazard Analysis, DFMEA, and risk management report, adhering to ISO 14971 standards. Responsible for maintaining highest standards of product reliability and patient well-being through gather and analyze data, write reports, and communicate with regulatory agencies on ensuring product safety. Responsibilities may include the following and other duties may be assigned: Capability to conduct thorough reviews of new and modified product design documentation, assessing quality characteristics such as manufacturability, serviceability, testability...

A Day in the Life A Day in the Life The Software Test Engineer will focus on supporting medical device software testing. The position is a hands-on test development & individual contributor role with a dynamic set of responsibilities in a complex software system including test design & development, design of test automation framework, test scripts development and test execution. Responsibilities may include the following and other duties may be assigned Test execution and document software using manual and/or automation methodologies. Thoughtfully develop testing strategies and protocols with state-of-the-art software best practices. Develop test strategies, review test designs, and validate...

Career Category Quality Job Description Let s do this. Let s change the world. In this vital role you will act as the Quality Engineering representative on multi-functional teams, employ quality principles and company s procedures including but not limited to the areas of device design control, Change Control and NC/CAPA, Risk Management, Human Factors Engineering, to ensure development and lifecycle management of final product align with dynamic global regulations and standards. The Sr Quality Engineer will be an integral part of the design and development of combination products, providing quality oversight of the processes and deliverables generated throughout development and commercializ...

Manage Change Notices in Windchill PLM, handle QMS docs and CAD files, process ECNs/ECRs, ensure ISO 13485 compliance, support QMS improvements, and collaborate globally for timely and accurate documentation Required Candidate profile This is for quality management document control.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Gurgaon, Haryana, India Job Description: Required Qualification...

A Day in the Life Be a part of the Medtronic Engineering and Innovation center (MEIC) by applying your skills to the growth and development & sustaining efforts of Medical Devices products at MEIC. As a member of the MEIC team, you will collaborate with the broader Medical Devices engineering team, clinical and commercial teams globally. You will enable design & development of medical devices/products and the associated infrastructure & capability building elements in close conjunction with the Global teams. Responsibilities may include the following and other duties may be assigned Experience in distributed product development, team building skills, talent management, conflict resolution, b...

Job Summary: Responsible for managing day-to-day operations of the calibration lab, maintaining documentation, ensuring compliance with ISO/IEC 17025 and regulatory requirements, and overseeing calibration activities for thermal and biomedical devices. Acts as the coordinator equipment traceability, and calibration data management. Key Responsibilities: Maintain and control all calibration-related documents such as SOPs, calibration procedures, master equipment records, and logbooks. Review calibration results and ensure correctness before issuing certificates. Monitor the validity and performance of master equipment and arrange for their periodic calibration. Maintain equipment history card...

Job Summary: Seeking a detail-oriented and proactive Field Auditor to evaluate and ensure compliance of service activities and office operations with company standards and regulatory requirements. The Field Auditor will be responsible for conducting on-site audits at hospitals and office locations, reviewing service engineer performance, inspecting documentation, identifying non-conformity, and recommending corrective actions for continuous improvement. Key Responsibilities: Conduct field audits of service engineers at hospital sites to verify adherence to service protocols, safety standards, and documentation practices. Audit office operations including documentation control, inventory mana...

Seeking an experienced RPA (Robotic Process Automation) Developer to join our team. As a developer, you will be responsible for in working in a project team in developing, testing and the processes as per client needs. Qualifications and Experience: Skills Required: Design, Develop and test: Development of RPA processes using any of the RPA tools, test the processes and deploy to production. Proven experience of 2+ years as an RPA Developer and implementing RPA solutions. Knowledge or experience in creating frameworks, modifying, and maintaining. In-depth knowledge and experience on RPA tools such as UiPath, Automation Anywhere, or Blue Prism(any 1 tool) Working with Orchestrator and Control...

Senior Test Engineer As a Test Engineer / Senior Test Engineer, you will be responsible for designing, implementing, and maintaining automated systems. Your role will be critical to enhancing and upholding highest standards of efficiency, quality, and reliability of high-impact systems and applications of our industry-leading clients including Fortune 500 enterprises. You will work on various mission-critical automation projects and collaborate with cross-functional teams to integrate automation technologies successfully across the organization. Key Responsibilities: Develop test plans to ensure automated systems meet performance, safety, and functionality standards. Execute automated tests,...

Experience 5-10 Years Job Type Full Time Key Responsibilities: Engaging with prospects through Emails / LinkedIn and other channels to generate interest in QualiZeal s service offerings. Research, identify, and segment prospects based on company profiles and LinkedIn data Qualifying prospects based on their Industry / Revenue / Geography Adding new companies/contacts in the assigned territory leveraging appropriate tools (LinkedIn, ZoomInfo, and others) Maintaining a database of prospects with proper hygiene. Managing outreach campaigns with a focus on deliverables and outcomes. Follow up with prospects in a timely manner and set up meetings for sales folks to pitch to Timing is key Qualific...

Experience 20+ Years Job Type Full Time Key Responsibilities: Strategic Leadership: Shape and execute the strategic vision for Quality Engineering and Testing Services across BFSI, Retail, and Energy & Utilities. Lead high-performing teams to deliver innovative, client-focused solutions. Drive thought leadership through the adoption of modern QE practices, automation, and AI technologies. Operational Excellence: Oversee end-to-end delivery of testing services to ensure high-quality, on-time outcomes. Establish and track KPIs to monitor performance, productivity, and client satisfaction. Streamline operational processes to enhance efficiency and scalability across global teams. Domain Experti...

Job Title Software Quality Engineer Job Description Job title: Software Quality Engineer Your role: Ensures that appropriate SW Quality plans are made that include all stages of the software life cycle and supports SW Quality Plan design. Validates key design inputs (i. e. usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs). Provides effective oversight of the execution of the SW Quality Plan and any Risk Management activities, and of all design related activities during the software lifecycle. Can lead quality related problem solving for software. Use post-market analytics and statistics...

Job Purpose : (what contribution is this position supposed to make in business?) The QMS and EU MDR Compliance Executive is responsible for ensuring compliance with ISO 13485, EU MDR (Regulation EU 2017/745), and other applicable quality and regulatory requirements. This role will support the development, implementation, and maintenance of the Quality Management System (QMS), oversee documentation control, conduct internal audits, and support regulatory submissions and audits as required. Key Deliverables/Responsibilities of this position 1- Quality Management System (QMS): Maintain and improve the ISO 9001:2015 / ISO 13485:2016-compliant Quality Management System. Ensure effective implement...

Job Summary Product Quality supports and collaborates with the Engineering group and Cross Functional teams to enable a diverse range of product releases in an efficient and compliant way. This role is focused on Strategy & Delivery Excellence - enabling velocity of product releases in alignment with established strategies, while also providing expertise to inform new strategies and improve design control processes, systems and tools. Let s talk about Responsibilities Author and communicate the project QA plan to enable new product implementation or changes to released product in an efficient way that satisfies ResMed s Quality System, regulatory requirements (e.g. ISO13485, CFR820, MDSAP), ...

Role & responsibilities Architect and implement a lean, auditready ISO13485:2016 Quality Management System and drive certification. Own all designcontrol documentation (SRS, DHF, Risk Management File, DMR, Technical File, etc.) in collaboration with engineering teams. Define and execute regulatory strategies: first CDSCO (ClassII/III), then FDA 510(k), and EU MDR CE Mark. Prepare, review, and submit regulatory dossiers; interact with authorities and notified bodies. Plan and conduct internal audits, manage CAPA investigations, and lead continuousimprovement initiatives. Qualify and monitor suppliers/CMOs; establish incoming and inprocess quality controls and batchrelease records. Train cross...

Required Qualifications: Bachelors or master’s degree in mechanical, electrical, or Systems Engineering , or a related technical field. 3+ years of experience in V&V for medical devices , ideally with complex systems involving fluidics, embedded systems, or renal therapy technologies . Hands-on experience designing and executing verification tests for software-controlled electromechanical systems. Strong knowledge of systems engineering principles , including the V-model , requirement validation, and test traceability. Proficient in using lab instrumentation (e.g., flow meters, pressure sensors, data acquisition systems).

Additional Locations: India-Haryana, Gurgaon Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we ll give you the opportunity to harness all that s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we ll help you in advancing your skills and career. Here, you ll be supported in progressing - whatever your ambitions. Key Responsibilities: Read and interpret technical drawings, procedures, and protocols. Import and maintains the project documentation in online RM tool throughout all phase...

Job Description Summary In this role you will develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. You will ensure that projects and products are capable and will meet specified standards (Preventive). You will have In-depth understanding of key business drivers; uses this understanding to accomplish own work. You will ensure each project is developed & released meeting customer expectations and regulatory requirements . GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and jo...

Job Description: OptraSCAN is seeking a highly detail-oriented and knowledgeable Regulatory Specialist - Technical Writer to create, manage, and maintain regulatory documentation required for product approvals, certifications, and market access in global markets. This role involves a combination of regulatory strategy and high-quality technical writing for medical devices (hardware and software), with a focus on ensuring compliance with international standards such as ISO 13485, FDA 21 CFR Part 820, EU MDR, and others. Key Responsibilities: Regulatory Documentation & Submissions. Prepare and maintain high-quality regulatory documentation including: Technical Files / Design Dossiers Clinical ...

Key Responsibilities : Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable international quality standards. Support design control, risk management, validation, and verification processes for scanners and software. Maintain and improve the Quality Management System (QMS) across departments. Review and approve SOPs, DHRs, DHFs, CAPAs, NCRs, and change controls. Conduct internal audits and support external audits (e.g., customer, notified bodies, FDA). Collaborate with engineering, manufacturing, and regulatory teams to ensure product quality at every stage of the lifecycle. Support software validation and documentation of AI algorithms per FDA/CE/MDR requirements. Part...

Additional Locations: India-Haryana, Gurgaon Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we ll give you the opportunity to harness all that s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we ll help you in advancing your skills and career. Here, you ll be supported in progressing - whatever your ambitions. Key Responsibilities: Read and interpret technical drawings, procedures, and protocols. Import and maintains the project documentation in online RM tool throughout all phase...

Senior Systems Engineer Location: India (Remote) Welcome to Natus Medical Incorporated: We re the leading manufacturer of medical devices and software for a range of specialities, including new-born care, neurology, sleep, hearing and balance markets. Our mission is to improve patient outcomes in target markets through innovative screening, diagnostic and treatment solutions. Job Summary: The Senior Systems Engineer is responsible for the risk management (RM), design and requirements specification, usability engineering, and compliance engineering of medical electrical systems used in Neurology, Audiology, and Newborn Care products. You can expect to be involved in all phases of the product ...

Job Title Principal Test Architect - Strategy & Automation Job Description Join Philips as a Principal Test Architect - Strategy & Automation for Image Guided Therapy (IGT) Systems and take a leading role in shaping the long-term verification & validation strategy for our X-ray system modality. This is a principal-level role, responsible for defining multi-year test strategies, advancing automation frameworks, and ensuring compliance with global regulatory standards. You will drive enterprise-level test architecture, collaborating with system architects, project architects, and development leaders to embed best-in-class test methodologies. Your work will influence the entire product lifecycl...