15 Eumdr Jobs

Responsible for supplier audit planning, scheduling, and conduct supplier audits. Responsible for vendor/ supplier quality and management issues. Responsible for implementation of ISO 13485 requirements Responsible for formulating, document, and maintain quality standards and ongoing quality objectives. -Analysis of raw material, In-process samples, and finished product. -Auditing OEM and verify the process control and quality, suggest changes if required to improve quality. -Responsible to escalate technical issues to the design team and Providing product feedback and customer suggestions to the R&D and Product Management team, also tracking the continuous improvement of the products. -Resp...

Job Description Summary Manages all Quality Assurance activities associated with the product development and product support processes in BD TCI. Ensures that all Design Control quality elements are established and documented to provide a safe and effective product that meets customer needs. Lead evolution and improvement of the product development process, policies and procedures which will enable design teams to respond rapidly to customer needs. Runs multiple projects directly while managing other quality engineering resources running separate projects. Provides leadership, quality oversight and direction, scheduling, decision-making, problem-solving and team-building capabilities. Mainta...

Job Description Summary Manages all Quality Assurance activities associated with the product development and product support processes in BD TCI. Ensures that all Design Control quality elements are established and documented to provide a safe and effective product that meets customer needs. Lead evolution and improvement of the product development process, policies and procedures which will enable design teams to respond rapidly to customer needs. Runs multiple projects directly while managing other quality engineering resources running separate projects. Provides leadership, quality oversight and direction, scheduling, decision-making, problem-solving and team-building capabilities. Mainta...

As a Mechanical Design Engineer supporting EU MDR compliance, you will be responsible for utilizing your 5-7 years of experience in the Medical device industry. Your key responsibilities will include ensuring good Documentation Practices, understanding Design input/Output/Verification deliverables, and complying with EUMDR or regulatory requirements. Additionally, you will be expected to stay updated on new technologies and industry practices, while being a quick learner capable of delivering with minimal intervention. Strong verbal and written communication skills are essential for this role. To qualify for this position, you should hold a Bachelor's degree in Mechanical Engineering or an e...

Led design & development/sustenance of Class II/III medical devices (electromechanical, disposable, implantable). Managed Design History Files (DHF) and ensured compliance with ISO 13485 , IEC 60601 , FDA & EU MDR . Led risk management (ISO 14971) activities including FMEA (Design & Process) and hazard analysis. Developed design inputs/outputs, V&V plans , test protocols, and technical reports. Collaborated with cross-functional teams (QA, RA, Manufacturing, Supply Chain, Clinical) for design transfer . Conducted design reviews to ensure safety, reliability, and manufacturability. Executed test method & process validations ; supported FEA coordination for design analysis. Contributed to regu...

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 understandi...

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....

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 artwor...

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 ...

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, Marketi...

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 suppo...

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 an...

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 medica...

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 Sy...