325 Iso 13485 Jobs

The Senior Technical Product Owner (TPO) will lead the definition, prioritization, and delivery of software features for next-generation medical device platforms. This role acts as the primary interface between product management, engineering, quality, and regulatory teams to ensure software solutions meet clinical needs, regulatory standards, and business objectives. Key responsibilities include managing the software backlog, translating vision into actionable requirements, driving cross-functional alignment, overseeing development processes (Agile/Scrum and V-Model), and ensuring compliance with medical device standards. The TPO will also lead risk management activities, facilitate Agile c...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Radiometer, 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 Radiometer, life comes first. Our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. As a global leader and pioneer in acute care diagnostics for over 70...

Job Title: Sr Recruiter - (Healthcare Manufacturing/ Medical Device) Location: Vastrapur, Ahmedabad Shift Timings: 7:00 PM to 4:00 AM (U.S Shift) Mon - Fri 100% Onsite Role Experience Required: 1 4 years Job Summary: Specializes in recruiting for medical device design, engineering, quality, manufacturing, and regulatory roles. knowledge of GMP/FDA/ISO standards. About the Role: 14 years of full-cycle recruitment experience in medical device, healthcare, or pharmaceutical industries. Proven experience supporting clients such as Boston Scientific, Medtronic, DaVita, Abbott, Stryker, or similar. Strong understanding of GMP, FDA, and ISO 13485 environments. Proficiency with ATS systems (JobDiva,...

Key Responsibilities Provide quality support to design and development teams. Review and approve design control documents (DHF, DMR, Risk Management File). Ensure compliance with ISO 13485, ISO 14971, and applicable regulatory standards. Participate in design reviews and risk assessments. Support verification, validation, and design transfer activities. Drive continuous improvement in design quality processes. Collaborate with cross-functional teams (R&D, Regulatory, Manufacturing, and Post-Market). Qualifications Bachelor's degree in Mechanical Engineering or related field. 7+ years experience in Design/Development Quality in the medical device industry. Strong understanding of ISO 13485, I...

1. Store Management: Maintain and control inventory of raw materials, consumables, and finished goods. Ensure compliance with STORE SOP (SOP/STR/02/00) and related documentation. Handle material inward/outward entries, delivery challans, and stock registers. Coordinate with production, QA, and dispatch teams for timely availability of materials. Maintain records for lot traceability, shelf-life items, and calibration tools as per QMS requirements. Ensure periodic physical verification and reconciliation of inventory. 2. Purchase & Procurement: Raise purchase requests as per material requirement and reorder levels. Identify, evaluate, and negotiate with vendors for cost-effective procurement....

'QMS Knowledge of Regulatory standards CFR820 , ISO 13485 & 14971, 60601 Hands on experience on Risk Management. Good understanding of Post Market Survey and complaint handling. Design plan Medical Process DQC Deviation and CAPA preferred. Be a part of core project team and support the quality engineering across the entire development cycle Lead product risk management, usability, reliability and design validation efforts for new product development and design change projects. Lead the development and implementation of design verification and validation plans with project design lead. Lead the development of Critical to Quality (CTQs), design input and output documents. Lead the fixture qual...

'QMS Knowledge of Regulatory standards CFR820 , ISO 13485 & 14971, 60601 Hands on experience on Risk Management. Good understanding of Post Market Survey and complaint handling. Design plan Medical Process DQC Deviation and CAPA preferred. Be a part of core project team and support the quality engineering across the entire development cycle Lead product risk management, usability, reliability and design validation efforts for new product development and design change projects. Lead the development and implementation of design verification and validation plans with project design lead. Lead the development of Critical to Quality (CTQs), design input and output documents. Lead the fixture qual...

'QMS Knowledge of Regulatory standards CFR820 , ISO 13485 & 14971, 60601 Hands on experience on Risk Management. Good understanding of Post Market Survey and complaint handling. Design plan Medical Process DQC Deviation and CAPA preferred. Be a part of core project team and support the quality engineering across the entire development cycle Lead product risk management, usability, reliability and design validation efforts for new product development and design change projects. Lead the development and implementation of design verification and validation plans with project design lead. Lead the development of Critical to Quality (CTQs), design input and output documents. Lead the fixture qual...

The Senior Manager QMS will lead the development, implementation, maintenance, and continuous improvement of the company's ISO 13485-compliant Quality Management System across multiple manufacturing and support units. This role is critical to ensure consistent product quality, process efficiency, global regulatory compliance readiness, and a strong quality culture across the organization. Key Responsibilities: QMS Governance & Compliance Lead the organization-wide implementation and maintenance of ISO 13485:2016 , 21 CFR Part 820 , Schedule V MDR 2017 , and MDSAP -aligned QMS. Ensure all quality-related processes, documents, and records are compliant and audit-ready at all times. Conduct and...

About Us: Adiuvo Diagnostics is a deep-tech medtech company building next-generation diagnostic platforms that integrate optics, electronics, and AI to enable rapid, non-invasive infection detection at the point of care. Role Summary: We're seeking a Ph.D.-level Photonics Scientist to drive optical design, imaging, and system integration for Adiuvo's diagnostic technologies. The ideal candidate combines deep expertise in optics and photonics with practical experience in developing real-world hardware for biomedical or analytical systems. Key Responsibilities: Lead the design, prototyping, and optimization of optical subsystems (illumination, imaging, spectroscopy). Develop and implement opti...

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). In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area. He/she ensures each project is developed & released meeting customer expectations and regulatory requirements. The role is a key technical role that works closely with product engineering to ensure Design control Quality Management System Compliance for NPI and IB deli...

A Day in the Life Responsibilities may include the following and other duties may be assigned Conduct gap assessments of product development processes and documentation against applicable medical device standards and regulations. Evaluate compliance with: ISO 13485 (Quality Management Systems) ISO 14971 (Risk Management) IEC 62304 (Software Lifecycle) FDA 21 CFR Part 820 (Quality System Regulation) EU MDR (Medical Device Regulation), if applicable IEC 60601(Basic safety and essential performance of medical electrical equipment) Review risk management files, design history files (DHF), software documentation, and quality processes. Identify non-conformities, process weaknesses, and areas requ...

A Day in the Life Design Quality engineer to support tool package role for CST-ET projects Responsibilities may include the following and other duties may be assigned Review new and modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements. Ensure that product development projects and changes to existing products are conducted in compliance with FDA Quality System Regulations. Participate on cross-functional teams to review marketing requirements and to develop concise, unambiguous, con-conflicting, , and feasible product requirements that support the market needs Complaint Handling Exper...

Job Title QMS and MS Manager Job Description Job Title : QMS and MS Manager Job Responsibilities: Takes ownership of the Document and Change Control activities and training activities for the Personal Health Management System Supports the Document and Change Control activities of the Personal Health Quality Management System by contributing to the development, implementation, and revision of MS-QMS processes, including standard operating procedures (SOPs) and work instructions, ensuring their accuracy, clarity, and compliance with relevant standards. Leads and or supports PH Regions and PH CoEs QMS relevant activities and projects. Responsible for the translation of Management System and Qua...

Conduct regular field visits to OEMs, medical device manufacturers, hospitals, and R&D centers. Leverage existing industry network & contacts to generate new business opportunities. Build strong relationships with R&D professionals, scientists, project & NPD (New Product Development) teams. Generate and track leads, opportunities, and ongoing projects in the medical device sector. Achieve assigned sales ... Executive/ Sr. Executive Medical Device Faizabad, Faridabad, Noida - Apply JobItUs ATS Executive/ Sr. Executive - Medical Device Qualification: B.Sc - Other; B.Tech/B.E. - Other Engineering; MBA/MMS/MPM/PGDM - Marketing; MD/MS/DM - Pharmacy Job Description: Conduct regular field visits to...

Key Responsibilities: Implement and maintain QMS processes in compliance with ISO 13485 , 21 CFR 820 , and applicable SaMD standards. Ensure software development processes comply with IEC 62304 (software lifecycle) and IEC 82304-1 (health software product safety). Support risk management activities per ISO 14971 and ensure integration with software lifecycle processes. Prepare and maintain regulatory documentation (Technical File, DHF, RMF, Clinical Evaluation, PMS). Collaborate with R&D to ensure design controls, validation, and traceability are maintained for software releases. Support regulatory submissions (e.g., FDA 510(k), EU MDR Technical Documentation , IMDRF-based markets). Implemen...

We are currently seeking an experienced Global Regulatory Program Manager to help manage a new internal initiative within Oracle Health.In this critical role, you will help drive definition and clarity around customer excellence, specifically focusing on leveraging regulatory knowledge and technical expertise to ensure Oracle Health compliance is met on documentation required for conformity on all Oracle Health products deemed a medical device. The outcomes of this role are to define, measure, and hold Oracle Health product teams accountable to the newly defined operational bar established for global regulatory technical compliance. You will be specificallyresponsible for the successful mana...

We are currently seeking an experienced Global Regulatory Program Manager to help manage a new internal initiative within Oracle Health.In this critical role, you will help drive definition and clarity around customer excellence, specifically focusing on leveraging regulatory knowledge and technical expertise to ensure Oracle Health compliance is met on documentation required for conformity on all Oracle Health products deemed a medical device. The outcomes of this role are to define, measure, and hold Oracle Health product teams accountable to the newly defined operational bar established for global regulatory technical compliance. You will be specificallyresponsible for the successful mana...

Job Description Job Title : QMS and MS Manager Job Responsibilities: Takes ownership of the Document and Change Control activities and training activities for the Personal Health Management System Supports the Document and Change Control activities of the Personal Health Quality Management System by contributing to the development, implementation, and revision of MS-QMS processes, including standard operating procedures (SOPs) and work instructions, ensuring their accuracy, clarity, and compliance with relevant standards. Leads and or supports PH Regions and PH CoE's QMS relevant activities and projects. Responsible for the translation of Management System and Quality Management System conte...

As a Product Manager at mlHealth 360 , you will lead the next phase of development for our AI-driven Radiology solutions, including medical imaging diagnostic AI products. The ideal candidate will combine technical acumen, clinical understanding, and regulatory awareness to drive end-to-end product lifecycle from concept to deployment and compliance with Indian SaMD regulations. Key Responsibilities 1. Product Strategy & Roadmap Define and own the product roadmap for AI-based radiology applications in CT, MRI, and X-ray domains. Conduct market and competitive analysis to identify gaps, unmet clinical needs, and differentiation opportunities. Collaborate with leadership to align product goals...

Job Title QMS and MS Manager Job Description Job Title : QMS and MS Manager Job Responsibilities: Takes ownership of the Document and Change Control activities and training activities for the Personal Health Management System Supports the Document and Change Control activities of the Personal Health Quality Management System by contributing to the development, implementation, and revision of MS-QMS processes, including standard operating procedures (SOPs) and work instructions, ensuring their accuracy, clarity, and compliance with relevant standards. Leads and or supports PH Regions and PH CoE's QMS relevant activities and projects. Responsible for the translation of Management System and Qu...

Technical Writer (Medical Devices) Intern Location: Chennai IIT Madras Research Park (Onsite) Employment: Contract (6 months) with option to extend or convert to full?time Start: Immediate Salary: 10,000 per month Why this role Floaid is finalizing documentation for a new platform. We need a hands?on technical writer who can rapidly bring our User/Operator Manual , Service & Maintenance Manual , Installation & Commissioning Guide , and related controlled documents to release quality under a medical?device QMS. What you'll own (deliverables) Operator Manual (IFU): setup, priming, alarms, operating modes, UI walkthroughs, cleaning/sterilization, warnings/contraindications, symbol glossary (ISO...

Company Description Royal Surgicare Pvt. Ltd. is a trusted manufacturer and exporter of quality medical consumables, based in Santej(Gujarat, India). We offer a wide range of products for Infusion Therapy, Transfusion Therapy, Gastroenterology, Urology, Anesthesia, and General surgery. Our facility operates under ISO 13485: 2016 standards to ensure consistent product quality. We are committed to delivering reliable and precise medical solutions. Role Description Oversee all Quality Assurance and Quality Control activities to ensure product safety, quality, and compliance. Ensure adherence to ISO 13485, EUMDR and applicable regulatory requirements. Review and approve quality documents, SOPs, ...

Experience in Manual system testing (Experience in Medical device testing is a plus point). Understand, develop and execute verification test methods, protocols, and reports for verification. Design test cases to include test methodology, test setups, materials, equipment, procedure, and acceptance criteria by analyzing requirements. Hands on experience in End to End test process. Experience in functional testing Develop and maintain the testing artifacts as per QMS requirements. Hands on experience in regression testing and defect reporting / tracking. Good knowledge on Medical device standards like ISO 13485, ISO 14971, FDA, CE and IEC standards. Working experience on tools like JAMA, JIRA...

Job Title: Senior Trainer Validation (CQV, Equipment, Injection Mold, HVAC) Location: Remote Job type: Part-time Job Summary: To design, develop, and deliver comprehensive training programs on Commissioning, Qualification & Validation (CQV), Equipment Qualification, Injection Molding Process Validation, and HVAC System Validation. The trainer will ensure technical competency development across engineering and quality teams in compliance with international regulatory standards (USFDA, EU GMP, ISO 13485, etc.). Key Responsibilities: Develop and deliver training modules on: Commissioning, Qualification, and Validation (CQV) lifecycle Equipment Qualification (IQ/OQ/PQ) Process Validation for Inj...