17 Fda Qsr Jobs

Job Description Summary Job Description Job Description number: TCI-JD026 Reporting To: Staff Quality Engineer / Quality Manager Position Title: Quality Engineer Job Group: JG3 Department / Segment: Quality Engineering / BD Medical Location: Bengaluru, India About BD BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. The company develops innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD has 70,000 employees and a presence in virtually every country around the world...

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Togethe...

Key Responsibilities Support the preparation and maintenance of Technical Documentation in compliance with IEC 62304 and IEC 82304 standards for Software as a Medical Device (SaMD) and (SiMD) , EU MDR , FDA QSR (21 CFR 820) , and related regulatory requirements. Contribute to the software development lifecycle documentation as per IEC 62304 and organizational quality processes. Assist in defining and maintaining software risk management documentation aligned with ISO 14971 and IEC 62304 . Collaborate with cross-functional teams (Development, Quality, and Regulatory) to ensure traceability, accuracy, and completeness of design and verification artifacts. Review and update software lifecycle d...

Key Responsibilities Support the preparation and maintenance of Technical Documentation in compliance with IEC 62304 and IEC 82304 standards for Software as a Medical Device (SaMD) and (SiMD) , EU MDR , FDA QSR (21 CFR 820) , and related regulatory requirements. Contribute to the software development lifecycle documentation as per IEC 62304 and organizational quality processes. Assist in defining and maintaining software risk management documentation aligned with ISO 14971 and IEC 62304 . Collaborate with cross-functional teams (Development, Quality, and Regulatory) to ensure traceability, accuracy, and completeness of design and verification artifacts. Review and update software lifecycle d...

Job Description Summary Job Description Job Description number: TCI-JD026 Reporting To: Staff Quality Engineer / Quality Manager Position Title: Quality Engineer Job Group: JG3 Department / Segment: Quality Engineering / BD Medical Location: Bengaluru, India About BD BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. The company develops innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD has 70,000 employees and a presence in virtually every country around the world...

Were hiring a Senior Software QA Engineer to support the development and release of high-reliability medical imaging solutions. This role is central to ensuring our iOS and Android applications meet strict safety, performance, and compliance standards. In this domain, almost working isnt acceptableclinicians and patients rely on flawless performance. What Youll Do Collaborate with product, clinical, hardware, and software teams to define use cases and develop comprehensive test plans. Execute manual and automated test cases for mobile applications and integrated imaging devices. Build, enhance, and maintain automated test frameworks to improve product quality, compliance, and user satisfacti...

Job Description Summary Job Description About BD BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. The company develops innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD has 70,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues. About BD TCI BD, a 125-year-old global medical device company has started its Enterprise Center in Bangalore, India called BD Technology Campus India (TCI)....

Experience: 2 to 5 years Education: Bachelor's degree in Biomedical, Mechanical, or B.Pharm We are looking for talented professionals for roles in Quality Assurance , Regulatory Affairs , and Documentation in the Medical Devices domain. Skills & Requirements: Minimum 3 years of experience in Medical Devices Regulatory Affairs , Quality Assurance , or Documentation Strong knowledge of global regulatory frameworks: FDA QSR, ISO 13485, EU MDR, IEC standards Experience in DHF assessment and remediation Familiarity with FDA 21 CFR Part 820.30 and ISO 13485:2016 design control requirements Documentation skills validation reports, change control, deviation records Strong communication skills, both ...

Key Responsibilities Provide quality support to design and development teams. Review and approve design control documents (DHF, DMR, Risk Management File). Ensure compliance with ISO 13485, ISO 14971, and applicable regulatory standards. Participate in design reviews and risk assessments. Support verification, validation, and design transfer activities. Drive continuous improvement in design quality processes. Collaborate with cross-functional teams (R&D, Regulatory, Manufacturing, and Post-Market). Qualifications Bachelor's degree in Mechanical Engineering or related field. 7+ years experience in Design/Development Quality in the medical device industry. Strong understanding of ISO 13485, I...

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 Title: Quality Head Sudhir Srivastava Innovations Private Limited Location: Udyog Vihar, Phase-III, Gurgaon, Haryana Employment Type: Full Time Relevant Experience: 7+ Year's Salary: As per the Industry Standard Position Summary: SSII, an US based medical devices company engaged in developing and manufacturing class II & III Surgical Robots is seeking a Head Quality for its Gurgaon, India location. Join an organization with a passion for commercializing smart, effective and patient centric Robotics solutions. The Head of Quality is a key member of the site Leadership Team, and this role leads the SSII Quality and Quality System functions in India. This role will be a critical leader of a...

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 Life Sciences, one of Danaher's 15+ operating companies, our work saves livesand 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. At Beckman Coulter Life Sciences, we know time is the most critical facet in the laboratory today: time to get life-saving therapies to patients faster; reclaiming time by au...

About Halma: Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US. Our diverse group of nearly 50 global companies specialise in market leading technologies that push the boundaries of science and technology. For the last 42 years, the combination of our purpose, strategy, people, DNA and sustainable business model has resulted in record long-term growth in revenues and profits and an increase in dividend by ? 5% every year an achievement unrivalled by any company listed on the London Stock Exchange. Why join us ...

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...

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...

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...

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...