325 Iso 13485 Jobs - Page 2

About Us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world's most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance ind...

Tips: Provide a summary of the role, what success in the position looks like, and how this role fits into the organization overall. Responsibilities Participate in the implementation and maintenance of the management system compliance with relevant international quality standards and regulatory requirements (Such as ISO 13485, ISO 14971, MDR 2017/745, and 21 CFR part 820). Participate in development of Regulatory Strategy for upcoming products against GSPR requirements. Participate in the development of QA strategies, recommendations for Continual improvement, Quality planning in conjunction with the needs of the company, for each product range and Quality Management System. Sustain and acti...

Define and implement reliability strategies and frameworks for software systems. Collaborate with cross-functional teams to integrate quality and reliability engineering throughout the SDLC. Lead risk management activities including DFMEA, hazard analysis, and traceability. Design and maintain post-market monitoring and alerting solutions to proactively address issues. Conduct root cause analysis and drive effective CAPA implementation. Develop tools and automation for reliability testing and validation. Ensure system availability through redundancy, failover, and recovery strategies. Support audits, regulatory inspections, and compliance with IEC 62304, ISO 13485, and ISO 14971. Mentor team...

We are seeking a highly experienced Senior Data Scientist to join our Digital Team for Infusion Pumps product. As a Senior Data Scientist, you will play a critical role in developing and deploying AI/ML models that calculate clinical limits for infusion therapy executed with Infusion Pumps based on historical data of previous infusions. Your expertise in data science, machine learning, and software development will help us improve the accuracy and reliability of our product, ultimately enhancing patient care. Key Responsibilities: AI/ML Model Development Develop and deploy AI/ML models that calculate clinical limits for infusion therapy executed with Infusion Pumps based on historical data o...

Key Responsibilities: Develop and maintain a Software Verification Plan (SVP) per IEC 62304, ensuring coverage of all required activities (unit, integration, system, acceptance). Align verification activities with the organization's Quality Management System (QMS) as required by ISO 13485, ensuring all SOPs, templates, and records are used and maintained. Establish and maintain traceability between software requirements, risk controls, and verification tests. Oversee creation and peer review of verification protocols, test cases, test scripts, and test data, ensuring direct traceability to software/system requirements and risk mitigations. Ensure objective evidence (test records, logs, scree...

This is where your work makes a difference. At Baxter, we believe every person regardless of who they are or where they are from deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. ...

Responsibilities: * Ensure compliance with regulatory requirements for medicaldevices * Oversee radiation safety protocols and training programs * Manage licensing processes for medical devices * M.Sc(Medical Physics, Radiation Physics, Life sci eng.

Develop and maintain V&V strategy, plans, and protocols for ventilator systems in compliance with regulatory and quality standards. Define test methodologies for system-level, subsystem-level

Dear Candidates, Hiring For Top MNC Company Role : Embedded Device Manual Software Verification Location : Chennai & Bangalore Experience : 5+ Years of experience Notice Period : Immediate to 30 days Note : Walkin Drive on 25th Oct-25 Only one of interview and offer letter will be issued on the same day 5 + years of experience in Embedded Device Manual Software Verification Expertise in understanding the System and Software architecture, Test protocols, debugging and test execution. Basic Embedded C coding skills, understanding the design is essential( 50% C programming skills required or trainable) Experience in Test protocol design , review and update Hands-on work experience in communicat...

A Day in the Life Sr Design Quality Engineer role for ENT 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, EU MDR and inhouse Standards. Participate on cross-functional teams to develop product risk management file (risk management plan, Hazard Analysis, DFMEA, and risk management report) as per ISO 14971. Familiar with ISO 9001, ISO 13485, ISO 14971, I...

The Head of Regulatory Affairs will lead the regulatory function for Healthineers, Zone India, ensuring compliance with national and international regulations while supporting the company's strategic objectives. This role requires an experienced leader who can navigate the dynamic regulatory environment, advocate for the company's interests, and enable the successful registration, approval, and lifecycle management of medical devices in the Indian market. The individual will act as the primary point of contact with regulatory authorities, including the Central Drugs Standard Control Organization (CDSCO), and drive cross-functional collaboration to align business goals with regulatory require...

We are looking at Candidates who has exposure to the following : EHS compliance , hands on experience in handling ETP, PCB with 8 to 10 years work experience. Pollution Prevention Statutory Compliances Wastewater Treatment Job Description Position: Associate Manager EHS position Reports to: General Manager Dotted Line Reporting : Senior Manager Human Resources Location: Jigani, Bangalore, India Languages: English, Hindi, Kannada speaking (Preferable) Job Responsibilities Ensuring Safe and Healthy environment in the entire workplace. Co-ordination with external auditing agencies related to Safety, Health and Environment. Coordinate and foster continuous improvement of day-to-day Environmental...

Plan and execute production based on indents from Domestic, Tender and International Business. Coordinate with PPC and Purchase teams to achieve targets by maintaining appropriate inventory at in-process and raw material stores. Oversee production processes for Sutures, Mesh, Clinicel, Skin Stapler, Umbilical Cotton Tape, Endo Surgery products, Kits, Truloop, Wax, Arthroscopy, new products, samples and new codes. Collaborate with Sales and Marketing teams to ensure timely delivery and achieve organizational goals. Ensure production execution aligns with the approved plan and drive overall production realization. Actively contribute to corporate projects on innovation, cost savings, new produ...

Assistant Manager / Manager - R&D | NPD | 6 - 8 Years | Coimbatore Roles & Responsibilities Drive New Product Development (NPD) projects through the stage-gate process, including design inputs, prototyping, verification & validation, pilot builds and product launch. Manage documentation including design history files, test reports, change control and regulatory submissions. Conduct microbiology tests, validation studies and risk management activities such as DFMEA and hazard analysis. Engage and collaborate with suppliers for material selection, qualification and audits. Track project timelines, budgets and performance metrics, ensuring adherence to quality and regulatory standards. Ensure c...

About Us: Adiuvo Diagnostics is a deep-tech medical technology company developing next-generation diagnostic platforms that integrate optics, electronics, and artificial intelligence to enable rapid, non-invasive detection of infections at the point of care. Our interdisciplinary team brings together expertise in engineering, biology, and computational sciences to transform diagnostics globally. Role Summary: We are looking for a hands-on R&D leader to drive the research, design, and development of Adiuvo's diagnostic technologies. The role demands a balance between technical depth and practical product realization someone who can architect systems, mentor engineers, and personally contribut...

Title: Senior Platform Manager (Enterprise SaaS) Location: In Office, Bangalore Type: Full-Time The Role We re looking for a Platform Manager who can bring structure to chaos. You ll be defining the specs, juggling two customer-facing co-founders to get alignment on what gets built with a clear why. You ll ensure everything in the backlog is well-groomed, technically feasible, and mapped to real customer pain points as seen by different teams so that engineers can build fast and correctly the first time. The negative KR is the number of releases by the engineering team that get stuck in the beta environment because of a lack of stakeholder alignment. This means you ll do a bit of everything:...

Job Title: New Product Development Trainer Location: Remote Job type: Part -time Job Summary: We are seeking an experienced NPD Trainer with over a decade of hands-on expertise in medical device design, product development, validation, and regulatory compliance . The Trainer will be responsible for designing and delivering structured training programs to upskill engineers, technicians, and project managers in end-to-end new product development processes from concept to commercialization. The ideal candidate should possess strong technical depth, familiarity with ISO 13485, FDA 21 CFR Part 820, and Design Control requirements, and the ability to translate complex product development concepts ...

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 seeking a skilled and motivated Cyber Security Engineer to lead efforts in securing our Software as a Medical Device (SaaMD) offerings. This pivotal role ensures global compliance and best-in-class security practices throughout the software development lifecycle, anchored in standards like ISO/IEC 27001, ISO/IEC 27002, and ISO 13485. Key Responsibilities Security Control Implementation : Design, implement, and monitor robust security controls across the SaaMD SDLC. Align with ISO/IEC 27001, 27002, and ISO 13485 frameworks. Guide secure coding, DevSecOps practices, and vulnerability management. Apply a risk-based approach to identify and mitigate threats proactively. Compliance & Audit...

Provide Bio/Tox related change control project support as well as support / provide guidance to lower-level associates. Advanced knowledge related to Hollister product portfolio. Support Bio/Tox lab related supplier re-evaluations and external audits of Hollister (e.g. NSAI, FDA) with guidance. Provide Bio/Tox support (with minimal) to the complaint management process. Support solutions to root cause investigations for Bio/Tox laboratory test failures. Receive and give feedback / guidance to cross functional and lower-level associates. Support Bio/Tox related 3rd party audits. Support Bio/Tox related Regulatory activity. Support budget compliance and submission of purchase orders to support ...

Role & Responsibilities : New Product Development Manager (Medical Electronics You will be the responsibilities for Architect behind out next generation medical electronics devices; Your expertise will directly influence patient care and national self-reliance: End to End Product Design: Drive the entire product design and development lifecycle, from concept validation through to post launch support, design control. Pioneering Innovation : Conceptualize groundbreaking designs and expertly generates and evaluate prototype to push the boundaries of medical technology. Optimizing Manufacturing Excellence , develop and continuously improve Manufacturing processes by different methodologies. Stra...

Great that you're thinking about a career with BSI! Position: Medical devices auditor Location: India(home based) What Duties You'll Perform As a Regulatory Services business stream Client Manager(Auditor) you'll be responsible for frequently travelling and having overnight stays across the South Korea. You'll assess to ISO 13485 quality management systems, EU medical device regulations and MDSAP scheme on customer sites, write up comprehensive reports and present these to the client. You'll also have the opportunity for occasional international travel to the USA and Europe. You'll undertake extensive training to deliver in your role. This includes: ISO13485 Lead Auditor course, MDSAP (Medic...

Job Purpose: We are looking for a detail-oriented and committed Quality Assurance Executive to support and enhance our Quality Management System (QMS) in compliance with ISO 13485, 21 CFR Part 820, and other applicable regulatory standards. This role involves document control, audit support, CAPA management, and coordination with internal teams to ensure high-quality standards across operations. Educational Qualifications: Bachelor's and/or Masters degree in Pharmaceutical Sciences, Engineering, Biotechnology, Microbiology, or any relevant Life Sciences discipline. Specialization in Regulatory Affairs or Quality Assurance is preferred. Key Skills & Competencies: Strong understanding of ISO 1...

Seeking a Junior Technical Writer (0–1 yr exp) to create and maintain clear, compliant documentation for medical devices (IFU, manuals, brochures, data sheets). QMS knowledge preferred. Ideal for detail-oriented, eager learners. Required Candidate profile B.E./B.Tech (EE/ME/CS) with 0–1 yrs exp in tech writing. Strong English, MS Word skills; FrameMaker/InDesign a plus. Keen to learn medical docs.

Role & responsibilities Design and develop medical device mechanical components and assemblies from concept to production Take full ownership of assigned projects, ensuring on-time completion with minimal supervision Create detailed 3D CAD models, engineering drawings, and specifications with appropriate GD&T Select appropriate materials, components, and manufacturing processes for medical devices Perform engineering analyses including tolerance stack-ups, stress analysis, and failure mode investigations Collaborate with cross-functional teams including electronics, firmware, and regulatory affairs Design for manufacturability, reliability, and cost-effectiveness Develop and execute verifica...