10 Eumdr Jobs

At Capgemini Engineering, the world leader in engineering services, you will be joining a global team of engineers, scientists, and architects dedicated to helping the world's most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts continuously think outside the box to provide unique R&D and engineering services across all industries. A career with us offers endless opportunities where you can truly make a difference, and where no two days are the same. Your role will require 5-7 years of experience in the Medical device industry. You should have exposure to good Documentation Practices and a solid understanding of Design input/ Output/ Verification deliverables. Familiarity with EUMDR or regulatory requirements will be considered an added advantage. We expect you to stay updated with new technologies and current industry practices, be a quick learner, and deliver results with minimum intervention. Strong verbal and written communication skills are essential for this role. As part of the job requirements, you should hold a Bachelors Degree in Mechanical Engineering or an Equivalent Engineering Degree. Experience in Sustaining, Remediation, and New Product Development projects, along with their documentation in different phases, is crucial. Knowledge of ECO/ ECN routing will be beneficial, as well as experience and exposure to manufacturing/design/testing within the medical industry. Proficiency in CAD tools such as SolidWorks, CreO, and PLM is expected. Capgemini is a global business and technology transformation partner with a diverse team of 340,000 members across more than 50 countries. With a strong heritage of over 55 years, Capgemini is trusted by clients worldwide to leverage technology and address their business needs comprehensively. The company offers end-to-end services and solutions, combining expertise in strategy, design, and engineering with market-leading capabilities in AI, cloud, and data. In 2023, the Group reported global revenues of 22.5 billion, showcasing its commitment to delivering tangible impact for enterprises and society.,

At Capgemini Engineering, the global leader in engineering services, a diverse team of engineers, scientists, and architects collaborates to empower the world's most innovative companies. From cutting-edge technologies such as autonomous cars to life-saving robots, our digital and software technology experts push boundaries by offering unique R&D and engineering services across various industries. Embark on a career with us, where each day offers new opportunities to make a difference. With a minimum of 5-7 years of experience in the Medical device industry, you should possess a strong grasp of good Documentation Practices and understanding of Design input/ Output/ Verification deliverables. Familiarity with EUMDR or regulatory requirements will be advantageous, along with exposure to new technologies and current industry practices. As a quick learner, you should exhibit the ability to deliver with minimal intervention and demonstrate excellent verbal and written communication skills. Key Requirements: - Hold a Bachelors Degree in Mechanical Engineering or Equivalent Engineering Degree - Proficient in managing Sustaining, Remediation, and New Product Development projects, including the necessary documentation across different phases - Knowledge and experience in ECO/ ECN routing will be beneficial - Exposure to manufacturing / design/ testing within the medical industry will be an added advantage - Proficiency in CAD tools such as SolidWorks, CreO, and PLM is expected Capgemini is a global business and technology transformation partner committed to supporting organizations in their journey towards a digital and sustainable future. With a team of 340,000 members across 50 countries, we leverage our 55-year heritage to deliver impactful solutions that address the diverse needs of enterprises and society. By harnessing our expertise in AI, cloud, and data, combined with deep industry knowledge and a strong partner ecosystem, we help clients unlock the full potential of technology. In 2023, our global revenues amounted to 22.5 billion, reflecting our unwavering commitment to driving innovation and creating value for our clients.,

Job Title: Labelling Specialist - Medical Devices Location: Sanand, Ahmedabad Department: Quality Assurance Employment Type: Full-Time (On-Site) Reports To: Quality Manager Job Summary: We are seeking a detail-oriented and knowledgeable Labelling Specialist to manage the creation, review, and maintenance of labelling content for our medical devices. The ideal candidate will have a strong understanding of medical device regulations and be well-versed in labelling standards, particularly ISO 15223. This role is critical to ensuring our product labels are compliant, accurate, and aligned with global regulatory requirements. Key Responsibilities: Develop and maintain medical device labels artwork in compliance with applicable regulatory requirements. Ensure labelling content aligns with ISO 15223 (Symbols to be used with medical device labels, labelling and information to be supplied). Collaborate with cross-functional teams including Regulatory Affairs, Quality Assurance, R&D, and Marketing to gather and validate labelling information. Review labelling changes and provide regulatory input during product development and product updates. Ensure labels comply with regional regulations such as MDR (EU), FDA (US), and other relevant markets. Maintain labelling documentation and change control records in accordance with internal procedures. Monitor updates to labelling standards and regulations and assess their impact existing labelling. Qualifications and Requirements: Bachelor's degree in a scientific, engineering, or healthcare-related discipline. Minimum 2 years of experience in a regulated medical device environment, preferably in labelling or regulatory affairs. Strong knowledge of ISO 15223 and other applicable standards (e.g., ISO 20417, IEC 60601, UDI regulations). Familiarity with regulatory requirements for labelling under EU MDR, US FDA, and other global regulations. Experience with labelling software tools (CorelDraw, Adobe Illustrator or similar tools) and document control systems is a plus. Excellent written and verbal communication skills. High attention to detail and ability to work independently and in teams.

Join our Sustaining Project Team as a Design Quality Engineer. Handle DHF, risk management, V&V, doc control, and ensure compliance with quality systems & regulatory standards. Experience with PLCP, FMEA, and CAPA is preferred. Required Candidate profile This role is strictly focused on Design Quality Engineering. It does not include Regulatory Affairs or Post-Market Surveillance (PMS) responsibilities.

We are looking for a skilled and detail-oriented QA Executive to join our team. The candidate will be responsible for ensuring the quality and regulatory compliance of medical devices in line with EU MDR 2017/745 and Indian Medical Device Rules (IMDR). This role involves preparing, reviewing, and updating key technical and regulatory documentation and supporting post-market surveillance activities. Roles & Responsibilities Preparation, review, and updating of Technical Files as per EU MDR 2017/745 and Device Master Files (DMF) as per IMDR . Maintenance of General Safety and Performance Requirements (GSPR) documentation in compliance with applicable guidelines. Preparation of Risk Management Plans and Reports as per ISO 14971 and other applicable standards. Development and review of Clinical Evaluation Protocols and Reports (CEP/CER) as per MDR/IMDR guidelines. Preparation and maintenance of Post-Market Surveillance (PMS) , Post-Market Clinical Follow-up (PMCF) , and Periodic Safety Update Reports (PSUR) . Documentation of Design and Development activities, ensuring alignment with regulatory and internal design control requirements. Drafting and reviewing Usability Engineering Protocols and Reports in compliance with ISO 62366. Monitoring, tracking, trending, and reporting of all reportable events , including serious/adverse incidents and field safety corrective actions (FSCA) . Keeping up to date with current national and international regulations, standards, and best practices relevant to the medical device industry. Ensure proper handover of responsibilities to designated personnel during absence. Desired Candidate Profile Prior experience in quality assurance or regulatory affairs for medical devices. In-depth understanding of EU MDR 2017/745 , IMDR , and related standards (e.g., ISO 13485, ISO 14971, ISO 62366). Strong documentation and review skills. Attention to detail with good organizational and analytical abilities. Effective communication skills and the ability to work independently as well as in a cross-functional team.

Role & responsibilities Responsible for development, implementation, maintenance, and overall success of the companys quality and regulatory programs and strategies, including articulating quality standards and objectives, developing methods to embed quality into the product development and manufacturing processes, establishing vendor relationships and quality standards, and developing and implementing innovative programs to focus employees on improving product quality. Develop, implement, and support a comprehensive regulatory compliance strategy to meet global market requirements for our products and ensure alignment with our overall business strategy. Proactively partner with R&D, Marketing, and other groups to provide regulatory advice and guidance on meeting necessary requirements to place products on global markets. Ensure that regulated processes and systems are always inspection ready. Oversee the performance of internal and external audits. Review, edit, and maintain all departmental policies and procedures, including trainings, CAPAs, ECRs, and ECNs. Oversee the development of employees, talent, processes, and technology necessary to reach annual and long-term objectives as organizational leader for the QA/RA functions Serve as person responsible for regulatory compliance (PRRC). Other duties as assigned. Preferred candidate profile Extensive experience hosting regulatory inspections and interacting with regulators Strong understanding of global registration requirements and demonstrated track record of successful market access. Experience with computer software validation (CSV) and implementation for QMS and ERP software packages, including user requirements gathering and specification development, process workflow documentation, validation script writing, and IQ/OQ/PQ test case execution General understanding of ICH, cGMP, cGDP, FDA, ISO, MDR, Healthcare compliance and applicable regulations and industry standards regarding clinical research and regulation of medical devices Effective manager with ability to mentor and develop members of the QA/RA teams through coaching and effective performance management Proven ability to create culture of accountability and ownership Proven track record with establishing and maintaining strong internal and external partnerships. Must be able to work effectively at all levels in the organization in a matrix environment .and with external partners. Must demonstrate excellent written and verbal communication skills and work well with diverse teams and stakeholders in multiple locations. Must possess the ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities to meet deadlines and prioritize work on multiple projects. Highly independent and self-motivated and integrates well within a team. Physical Demands Ability to travel. Qualifications: Bachelors degree required in a science, engineering field or related discipline. MBA is a plus Experience: 10 years of QMS experience and demonstrated leadership experience. Proficiency with ISO 13485, Good Clinical Practices (GCP), and Quality System Inspection Techniques (QSIT); CFRs parts 210 &211.

Strong knowledge of FDA QSR, ISO 13485, EUMDR & regulatory norms. Manage QMS docs, DHFs, CAPAs, audits, suppliers, training & calibration. Support audits, product dev, quality improvements & regulatory compliance. Excellent doc & comm skills needed.QMS Management: Take ownership of QMS documentation, ensuring it's current, accurate, and accessible. Regulatory Compliance: Apply strong knowledge of FDA Quality System Regulation (QSR), ISO 13485, and EU Medical Device Regulation (EUMDR) to all quality processes. Design History Files (DHFs): Manage and maintain Design History Files, ensuring completeness and compliance throughout the product development lifecycle. CAPA Management: Lead and support Corrective and Preventive Actions (CAPAs), from initiation and investigation to implementation and verification of effectiveness. Audits: Facilitate and support internal and external audits (e.g., regulatory inspections, notified body audits), ensuring readiness and effective follow-up on findings. Supplier Quality: Oversee supplier qualification, monitoring, and quality agreements to ensure high standards across our supply chain. Training & Calibration: Manage and track quality-related training programs and ensure timely calibration of essential equipment. Cross-functional Collaboration: Partner with teams like Product Development to integrate quality requirements early in the design process and support overall quality improvements. Regulatory Submissions: Provide critical support for regulatory submissions, ensuring all necessary quality documentation is complete and accurate.

Role & responsibilities Preparation, Review and updation of Technical Files as per euMDR 2017/745 & DMF as per IMDR. General performance and safety records as per respective Guidelines. Risk Management plan & reports as per respective guidelines. Clinical Evaluation protocol & Report as per respective Guidelines. PMS,PMCF & PSUR plan & report as per respective Guidelines. Design & Development documentation & report as per respective Guidelines. Usability engineering protocol & report as per respective Guidelines. Track & Trend & report all Re-portable events,including serious/ adverse incidence, field safety corrective Keep up to date with national and international legislation,guidelines and customer practice. In absence, charge shall be handed over to the designee.

Job Description: Degree in mechanical engineering, electrical engineering, applied sciences or a related discipline; 10+ years of professional experience in medical device in Risk management , regulatory Quality systems EU MDR, US FDA and closely working R&D, Regulatory Affairs & design quality organizations Strong proven experience in simplifying/reviewing RMM,BRD, RMF, Trace matrix, DHFs, Design requirements, IFUs, Risk management , V&V activities etc. Expertise in interpreting & implementing various medical device standards and guidance's, such as IEC , ISO. Experience with systems for quality management, product development, and follow-up of procedures Knowledge and application of medical device QMS is required (e.g., ISO 13485, MDSAP, EU MDR, Risk Management etc.) Ensures that appropriate Quality Plans are made that include all stages product life cycle ,supports Quality Plan Validate key design inputs like : Usability, Reliability, Performance, Supportability, Manufacturability, Safety, Security, Privacy, Serviceability, Sustainability etc. Provides effective oversight of the execution of the Quality Plan, Risk Management activities, and all design related activities during the product/system life cycle Performs independent technical assessment on product quality performance and post-market product quality analysis 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 Act as a single point of contact (person assigned to project team) responsible t ensure that hardware design meets quality and compliance standards for every milestone etc.)

Why join AliveCor? At AliveCor, we imagine a healthier world powered by access to personalised intelligent information. Heart disease kills more people than anything else in the western world, including all cancers combined. We're on a mission to be the worlds heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical EKG 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, hundreds of thousands of users have taken more than 100-million heart health measurements and counting. The Opportunity: AliveCor seeks a Quality System Specialist join this exciting start-up that is changing the face of mobile health. In this role, you will be responsible for the hands-on, day-to-day support of AliveCor’s Quality Management System (QMS) to ensure compliance to company procedures, FDA QSR, ISO 13485, EUMDR and other regulatory standards. Main duties include the processing and maintenance of all QMS-related documents and records, related to product design history files, CAPAs/NCs, training, external standards, suppliers, audits, and calibration. Additional responsibilities include supporting internal and external audits and quality improvement initiatives. This role requires the candidate to be based out of our office in Bangalore, India. Responsibilities: Support the Quality Systems Manager in the management of AliveCor’s QMS Maintain AliveCor’s electronic document control database to ensure the efficiency of AliveCor document control process and compliance to AliveCor and regulatory standards Manage creation, revision, and obsolescence of SOPs, Work Instructions (WRKs), and forms in accordance with document control procedures and assist AliveCor team members with processing of urgent documents, reminders, and status updates, as needed Assist in compiling and organizing design inputs, risk management files, verification/validation reports, and other technical documentation. Support new product development teams in maintaining robust design controls by verifying that Design History Files (DHFs) accurately reference the current document numbers, revisions and associated Quality Records. Manage training records and assignments for quality-controlled procedures, including coordinating document revisions, running overdue training reports, sending overdue reminders, administering quizzes, facilitating password resets, and maintaining records per retention policies. Assist CAPA and NC owners with ensuring completeness of records. Prepare monthly meeting metrics, maintain logs, and send reminders for required activities (i.e. due dates and effectiveness checks) Manage and maintain the Approved Supplier List (ASL), ensure documentation is up-to-date for all suppliers, and coordinate activities related to supplier qualification, periodic re-evaluation, and audits in accordance with the Supplier Control procedures. Assist in the preparation of documents/metrics for Management Review meetings and maintain meeting records Support internal, supplier, and regulatory audits by ensuring documentation readiness, process adherence, compiling required deliverables, and tracking post-audit findings through to timely corrective action and closure. Maintain comprehensive calibration logs, coordinate timely calibration activities with internal teams or external metrology vendors, ensure accurate documentation of all measuring and monitoring equipment, and proactively verify compliance with established calibration schedules and quality standards. Support the integration of new requirements into the Quality Management System and applicable procedures to ensure ongoing compliance. Coordinate, manage, and lead programs related to quality improvement or business objectives as assigned by Quality System Manager and assist other functional areas, as needed Requirements: Bachelor’s degree in Science or Engineering 5+ years of document control, QMS management, supplier management, and/or training administration function in the medical device or other regulated industry Working knowledge of FDA QSR (21 CFR 820), ISO 13485, EUMDR and applicable standards (ISO 14971, IEC 62366, etc.). Prior experience with electronic document management systems and/or learning management systems (LMS). Experience with Master Control is a plus Knowledgeable of Good Documentation Practices to perform and execute job responsibilities with a high level of accuracy Demonstrated ability to communicate effectively with internal and external customers and develop expertise to provide improved assistance Have good communication skills, both written and verbal. Strong editorial and technical writing skills a plus Excellent organisational skills along with strong attention to detail Ability to work both independently and collaboratively with small, cross-functional teams Highly proficient with Microsoft Office Suite and Adobe Acrobat Perks and benefits: We strive to make your life outside work as smooth as possible while you're at work, and we offer a long list of benefits to make that happen. Hybrid working model Flexible and generous vacation policy Maternity / Paternity Leave/ Adoption/ Commissioning leave Generous Medical Benefits: Above market family floater medical insurance coverage including both parents or parents-in-law Metro connectivity from office A supportive, collaborative group of people who understand that success depends on the team