7 Iso 14971 Jobs

Job Description The Software Quality Engineer is responsible for Software Quality relative to the design and development of company products, software reliability, developing and maintaining processes and procedures, and assuring adherence to the software development lifecycle across Abbott. Responsible for maintaining a strong collaborative partnership with cross-site and cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. About the team: The Software Quality Engineering team provides a fast-paced, dynamic work environment where engineers work closely with cross functional teams to provide software services to patients and physicians while keeping Quality foremost on our mind. You will collaborate with other engineers in in from the various R &D teams to continue finding new areas that can be improved by bringing a while also conducting testing, ensuring compliance with regulatory standards, and integrating best practices in the Quality Management System. We re passionate about building products that improve the quality of life for patients. We like to learn along the way and depend on everyone s input to help us grow as a team. Position requirements: Bachelor s Degree ( 16 years) in Computer science, software engineering, or a closely related discipline Or Master s degree. Minimum of 4 years of related work experience in quality or related field. Minimum of 3-5+ years of combined experience in software development web-based, client-server, and/or embedded systems applications Minimum 3-5+ years of combined experience in software testing andverification/validation Experience developing automation frameworks and scripts using Selenium, and/or Appium, UFT, etc. Programming experience in C/C#/Visual Studio/Java, Scripting Language such as Python, Ruby, Perl Experience with software configuration, and issue tracking tools such as GIT, Jira, Subversion, ClearQuest, Doors, Bugzilla. Experience as team-member in Agile SDLCprojects/programs Knowledge of various types of SDLC s and TLC s (V-Model, Iterative, Agile/Scrum, etc.) Working experience in behavior-driven testing and scripting using cucumber or behave. Experience in automated test execution using Selenium and Appium. Ability to follow processes per defined Quality Management System Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes, and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail. Good to have: Experience using overall test management tools such as Microfocus ALM, Zephyr, Test Complete. Experience in code review/static analysis tool(s) to aide code review such as Code Collaborator, Coverity, Parasoft DT Experience working in a broaderenterprise/cross-divisionbusiness unit model. Working experience in mobile test automation tools (e.g. Perfecto, MobileLabs) Working knowledge of 21 CFR part 820, IEC 62304, IEC 82304-1, ISO 14971, and ISO 13485

Position: Manufacturing Process Engineer Reporting to: Quality Manager Location: Pillaipakkam (Factory) Summary: As a process engineer, you will analyse and optimize manufacturing and industrial processes to improve efficiency and reduce costs. This includes process designing, troubleshooting, process optimization, process analysis, process documentation, quality control, project management, process automation and quality assurance. You will also collaborate with cross-functional teams, implement process improvement initiatives and contribute to the overall success of our organization. Roles responsibilities: 1.Conduct detailed process evaluations and gap analyses to identify areas for improvement in existing manufacturing operations. 2.Design and implement process optimization strategies to improve efficiency, reduce cycle times, and enhance product quality. 3.Collaborate with Engineering, Production, and Quality teams to develop and maintain Standard Operating Procedures (SOPs) and Work Instructions. 4.Monitor key process performance indicators (KPIs) such as cycle time, yield, scrap rate, and Overall Equipment Effectiveness (OEE) to meet or exceed operational targets. 5.Establish and maintain process control measures, including Statistical Process Control (SPC) techniques, to reduce variability and ensure consistent product quality. 6.Provide technical troubleshooting support to resolve process-related issues and improve equipment performance. 7.Lead process validation activities, including protocol development, execution, and documentation in compliance with regulatory standards (ISO 13485, 21 CFR Part 820). 8. Participate in root cause analysis, corrective action, and preventive action (CAPA) initiatives for process deviations and product quality issues. 9.Deliver training and provide guidance to production teams on new processes, procedures, and equipment to ensure successful implementation. 10.Stay current with advancements in process engineering, lean manufacturing, and automation technologies to continuously improve production capabilities. Required Skills and Qualifications: i. Bachelors degree in Mechanical, Plastics, Metallurgical, Process Engineering. ii.2-3 years of experience as a Process Engineer in a manufacturing environment, preferably in medical device or medical product manufacturing. iii. Strong knowledge of process optimization, lean manufacturing, Six Sigma, and statistical analysis. iv Proficiency in process modeling, data analysis, SPC, and process simulation software. v. Excellent problem-solving and analytical skills with the ability to manage complex process challenges. vi. Working knowledge of process safety, risk assessment, and regulatory compliance (ISO 13485, ISO 14971, FDA 21 CFR Part 820). vii. Effective communication and interpersonal skills for cross-functional collaboration. Strong project management abilities with proven capability to manage multiple priorities and deliver within deadlines. Preferred candidate profile Bachelors degree in mechanical, plastics, Process engineering, knows the regulatory compliance

Looking for candidates with 2–4 years of strong PMS experience in the medical device domain (preferably ortho/trauma). Must be skilled in EU MDR, PSUR, trend reports, risk assessment (ISO 14971), and complaint handling. Required Candidate profile Note: This role is exclusively for PMS professionals with hands-on experience in medical devices.

Job Title: Embedded Software Engineer Medical Device Technology Location: Pune Department: Engineering / Embedded Systems Employment Type: Full Time Company Overview: InnoIQ Engineering , a subsidiary of B&W Engineering und Datensysteme GmbH, Germany , is a leading company specializing in the research, design, and development of innovative medical devices . With a strong focus on precision, quality, and customer-centric solutions , we collaborate with global clients to bring advanced medical technologies to life. From concept design and prototyping to production support , we offer comprehensive engineering solutions tailored for the medical device industry . Position Summary: We are seeking a passionate and detail-oriented Embedded Software Engineer to join our growing engineering team. You will play a critical role in the development of embedded software solutions for cutting-edge medical devices , ensuring compliance with regulatory standards and delivering high-quality products that positively impact patient care. Key Responsibilities: Design, develop, test, and maintain embedded software for medical devices Collaborate with cross-functional teams including electronics, mechanical, and system engineers Write efficient, reliable, and reusable code in C/C++ for embedded platforms Contribute to software architecture and system integration for real-time embedded systems Conduct software verification, validation, and unit testing in accordance with IEC 62304 Support design documentation and risk management activities per ISO 13485 and ISO 14971 Debug hardware/software integration issues using appropriate tools and methods Participate in design reviews, code reviews, and continuous improvement activities Required Qualifications: Bachelors or Masters degree in Electronics Engineering , Computer Engineering , Embedded Systems , or related field 2+ years of experience in embedded software development , preferably in the medical device domain Proficiency in C/C++ programming and real-time embedded systems Experience with microcontrollers , RTOS , and hardware-software interfacing Strong understanding of software development life cycle in regulated environments Knowledge of medical standards such as IEC 62304 , ISO 13485 , and ISO 14971 Good problem-solving skills and attention to detail Proficient in written and spoken English Preferred Qualifications: Experience with wireless communication protocols BLE, NFC Familiarity with version control systems Git and tools like Jira, Confluence Experience in developing software under Agile or V-model process Why Join Us? Be part of a global team developing life-enhancing medical technologies Work in a culture that values innovation , precision , and continuous learning Opportunities to grow in a fast-paced , quality-driven , and regulatory-compliant environment Exposure to international projects and collaboration with leading medical device companies

Role & responsibilities: Process Development &Optimization Define, document, and improve engineering workflows, protocols, and D&D procedures. Collaborate with cross-functional teams (Design, QA/RA, Manufacturing, Supply Chain) to standardize and streamline development processes. Support Design Control processes including Design Inputs/Outputs, Verification, and Validation activities. Technical Documentation Management Create, maintain, and control engineering documentation such as: Design History Files (DHF) Device Master Records (DMR) Engineering Change Orders (ECO) Risk Management Files (ISO 14971) Ensure traceability and version control using QMS tools. Assist in the preparation and formatting of documents for regulatory submissions (FDA, EU MDR). Compliance & Quality Support Ensure documentation and processes meet applicable standards: ISO 13485, 21 CFR Part 820, IEC 60601, and other regulatory requirements. Support internal and external audits by providing required documentation and process maps. Knowledge Transfer & Team Support Maintain structured repositories of technical documentation and templates. Train engineers and D&D staff on documentation best practices, process adherence, and use of documentation tools. Tools & Systems Use and help maintain Product Lifecycle Management and Quality Management Systems (QMS). Work with tools such as SolidWorks PDM, Windchill, Arena, or equivalent for document and change control. Preferred candidate profile

Job Title Design Quality Engineer Job Description Job title: Design Quality Engineer - Medical Devices The Design Quality Engineer DQE provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met. The DQE also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes Your role: Ensure appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design. Validate key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability, and costs. Provide effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product/system lifecycle. Perform independent technical assessment on product quality performance and post market product quality analysis. Can Lead quality related problem solving and root cause analysis during design and manufacturing. Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required. Performs independent technical assessment on product quality performance and post market product quality analysis. Provide leadership and oversight to ensure Quality Management System Compliance. Be able to plan, control, and assure product and process quality in accordance with quality principles, which include planning processes, material control, acceptance sampling, and measurement systems. Ensure the compliance requirements are met during Design review , design verification & Design validation , Design transfer. Apply and facilitate Design for Quality & Reliability best practices (FMEAs, robust design, V&V, root cause analysis & problem solving). You're the right fit if: (4 x bullets max) An Engineering degree in any discipline with at least 8+ years of relevant industry experience. . Core expertise in Design Quality, Systems Engineering, or Reliability Engineering. Medical device industry experience is mandatory . Ability to define detailed systems quality and reliability plans for new medical product developments to ensure those are safe, effective and reliable. Ability to contribute to Risk Management and lead FMEA activities for new products and assurance that control measures are translated in appropriate critical requirements. Strong exposure to application of Design Controls ability to do thorough Design Reviews during new product development to ensure robust designs that further improve patient safety and product quality. Ability to partner with V&V teams to assure thorough Verification, Validation and Usability testing. Ability to lead reliability analysis to assess the risks associated with design concepts. Experience with adequate and accurate review of DHF and DMR documents. Understanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR, , and ISO 14971. Experience with working in multidisciplinary teams in a high-tech R&D environment. You continuously strive for excellence as a way of life and can inspire others to adopt this mentality of prioritizing quality above all else. You are a self-starter who embraces the change How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers or suppliers locations. Indicate if this role is an office/field/onsite role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. . Learn more about . . Discover . . Learn more about . If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion .

Designation: Staff Specialist Labeling & Technical Publications Experience: 7–11 years Location: Gurgaon (GGN) or Bangalore (BLR) Interview Rounds: 8 Work Mode: Hybrid / Onsite Role Overview We are seeking a highly skilled professional to manage and coordinate global labeling and technical publications for medical device products. This role involves regulatory documentation, translation workflows, quality compliance, and cross-functional project leadership within a regulated environment. Key Responsibilities Manage and approve labeling jobs using tools like Microsoft Teams Planner and PLM systems. Coordinate document translations with external vendors and ensure regulatory compliance. Publish approved documents to global portals and maintain accurate versions. Lead and support Engineering Change Requests (ECR/ECN) related to labeling and documentation. Act as the local labeling lead for global projects, tracking progress, managing stakeholders, and reporting risks. Ensure compliance with global quality and regulatory standards (EU MDR, ISO 14971, IEC 62366). Support risk management processes and integrate risk measures into product labeling. Review quality assurance documentation related to product sustenance and lifecycle management. Manage label printing for regulatory submissions and large-scale updates. Must-Have Skills & Qualifications 7–11 years of work experience, with 5+ years in technical writing, labeling, or quality assurance in the medical device domain. Hands-on experience with documentation systems such as onePLM, SharePoint, or similar. Solid understanding of regulatory frameworks including EU MDR, ISO 14971, and IEC 62366. Strong project management capabilities with the ability to manage multiple projects and timelines. Bachelor’s degree in Engineering, Science, or a related technical field. Excellent communication and stakeholder management skills.