4 Fda Qsr Jobs

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Beckman Coulter Diagnostics, one of Danaher's 15+ operating companies, our work saves lives-and 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. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making-we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. Learn about the which makes everything possible. The Senior Systems Verification Engineer I for Beckman Coulter Diagnostics is responsible for designing, developing, troubleshooting Electro-Mechanical / Opto-Electrical System modules for laboratory medical device new product development. The incumbent practices best design practices and follow quality processes defined during development. This position reports to the Head of Life Cycle Management & Group Manager and is part of the R&D Hardware/Systems Development team located in Bengaluru - BDC and will be an on-site role. In this role, you will have the opportunity to: Author, review, and executesystem-level test protocolsto validate design changes. Ensure test coverage foraccuracy,performance,throughput,carryover, andlinearityEtc. requirements. Analyze test data and generatestatistically sound reportsto support design verification and release decisions. Evaluate whether design changes meet existing system specifications/requirements and performance benchmarks and changes do not compromise product integrity or clinical outcomes. Participate in DFMEA reviews, identifying and testing for potential failure modes. Perform DFMEA test protocols to validate mitigations and assess risk impact. Develop and execute reliability test protocols, including accelerated life testing and environmental stress testing. Perform statistical analysis of reliability and performance data using tools such as Minitab, JMP, or Python/R. Interpret results to estimate product life, failure rates (MTBF = Mean Time Between Failures), and confidence intervals. The essential requirements of the job include: Bachelor's or Master's degree in Biomedical engineering, Electrical Engineering, Systems Engineering, or related field. 3+ years of experience in medical device V&V, preferably in diagnostics or imaging systems. Strong understanding ofdesign control,risk management, andreliability engineering. Proficiency instatistical analysisand tools for data interpretation. Familiarity withDFMEA,ISO 14971,IEC 60601, andFDA QSR. Experience insetting up experiments using external sensors and data acquisition systemssuch asLabVIEW, NI DAQ, or similar platforms. Experience with requirement management tools (e.g., IBM DOORS, Jama) is a plus. Familiarity with regulatory and safety standards (IEC 62304, ISO 13485, FDA Class II). It would be a plus if you also possess previous experience in: Experience in medical device design & development is a plus Experience in IVD instrumentation, such as clinical chemistry, immunoassay, hematology, urinalysis, molecular, microbiology or flow cytometry systems is a plus Familiarity with lean manufacturing and Six Sigma principles Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit .

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Beckman Coulter Diagnostics, one of Danaher's 15+ operating companies, our work saves lives-and 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. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making-we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. Learn about the which makes everything possible. The Senior Systems Verification Engineer I for Beckman Coulter Diagnostics is responsible for designing, developing, troubleshooting Electro-Mechanical / Opto-Electrical System modules for laboratory medical device new product development. The incumbent practices best design practices and follow quality processes defined during development. This position reports to the Head of Life Cycle Management & Group Manager and is part of the R&D Hardware/Systems Development team located in Bengaluru - BDC and will be an on-site role. In this role, you will have the opportunity to: Author, review, and executesystem-level test protocolsto validate design changes. Ensure test coverage foraccuracy,performance,throughput,carryover, andlinearityEtc. requirements. Analyze test data and generatestatistically sound reportsto support design verification and release decisions. Evaluate whether design changes meet existing system specifications/requirements and performance benchmarks and changes do not compromise product integrity or clinical outcomes. Participate in DFMEA reviews, identifying and testing for potential failure modes. Perform DFMEA test protocols to validate mitigations and assess risk impact. Develop and execute reliability test protocols, including accelerated life testing and environmental stress testing. Perform statistical analysis of reliability and performance data using tools such as Minitab, JMP, or Python/R. Interpret results to estimate product life, failure rates (MTBF = Mean Time Between Failures), and confidence intervals. The essential requirements of the job include: Bachelor's or Master's degree in Biomedical engineering, Electrical Engineering, Systems Engineering, or related field. 3+ years of experience in medical device V&V, preferably in diagnostics or imaging systems. Strong understanding ofdesign control,risk management, andreliability engineering. Proficiency instatistical analysisand tools for data interpretation. Familiarity withDFMEA,ISO 14971,IEC 60601, andFDA QSR. Experience insetting up experiments using external sensors and data acquisition systemssuch asLabVIEW, NI DAQ, or similar platforms. Experience with requirement management tools (e.g., IBM DOORS, Jama) is a plus. Familiarity with regulatory and safety standards (IEC 62304, ISO 13485, FDA Class II). It would be a plus if you also possess previous experience in: Experience in medical device design & development is a plus Experience in IVD instrumentation, such as clinical chemistry, immunoassay, hematology, urinalysis, molecular, microbiology or flow cytometry systems is a plus Familiarity with lean manufacturing and Six Sigma principles Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit .

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Beckman Coulter Diagnostics, one of Danaher's 15+ operating companies, our work saves lives-and 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. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making-we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. Learn about the which makes everything possible. The Senior Systems Verification Engineer I for Beckman Coulter Diagnostics is responsible for designing, developing, troubleshooting Electro-Mechanical / Opto-Electrical System modules for laboratory medical device new product development. The incumbent practices best design practices and follow quality processes defined during development. This position reports to the Head of Life Cycle Management & Group Manager and is part of the R&D Hardware/Systems Development team located in Bengaluru - BDC and will be an on-site role. In this role, you will have the opportunity to: Author, review, and executesystem-level test protocolsto validate design changes. Ensure test coverage foraccuracy,performance,throughput,carryover, andlinearityEtc. requirements. Analyze test data and generatestatistically sound reportsto support design verification and release decisions. Evaluate whether design changes meet existing system specifications/requirements and performance benchmarks and changes do not compromise product integrity or clinical outcomes. Participate in DFMEA reviews, identifying and testing for potential failure modes. Perform DFMEA test protocols to validate mitigations and assess risk impact. Develop and execute reliability test protocols, including accelerated life testing and environmental stress testing. Perform statistical analysis of reliability and performance data using tools such as Minitab, JMP, or Python/R. Interpret results to estimate product life, failure rates (MTBF = Mean Time Between Failures), and confidence intervals. The essential requirements of the job include: Bachelor's or Master's degree in Biomedical engineering, Electrical Engineering, Systems Engineering, or related field. 3+ years of experience in medical device V&V, preferably in diagnostics or imaging systems. Strong understanding ofdesign control,risk management, andreliability engineering. Proficiency instatistical analysisand tools for data interpretation. Familiarity withDFMEA,ISO 14971,IEC 60601, andFDA QSR. Experience insetting up experiments using external sensors and data acquisition systemssuch asLabVIEW, NI DAQ, or similar platforms. Experience with requirement management tools (e.g., IBM DOORS, Jama) is a plus. Familiarity with regulatory and safety standards (IEC 62304, ISO 13485, FDA Class II). It would be a plus if you also possess previous experience in: Experience in medical device design & development is a plus Experience in IVD instrumentation, such as clinical chemistry, immunoassay, hematology, urinalysis, molecular, microbiology or flow cytometry systems is a plus Familiarity with lean manufacturing and Six Sigma principles Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit .

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