215 Iso 13485 Jobs - Page 5

Prepare and submit regulatory dossiers for product registrations, import licenses, and amendments to the CDSCO. Maintain up-to-date knowledge of Indian medical device regulations (Medical Device Rules, 2017 and amendments). Liaise with CDSCO, state licensing authorities, and third-party regulatory consultants. Support Quality Assurance in audits, product recalls, and field safety corrective actions. Ensure compliance with India-specific labeling, documentation, and advertising regulations. Monitor and assess changes in regulatory guidelines and communicate impact to cross-functional teams. Maintain regulatory files and tracking systems for timely renewals and updates. Collaborate with global...

Additional Locations: India-Maharashtra, Pune Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we ll give you the opportunity to harness all that s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we ll help you in advancing your skills and career. Here, you ll be supported in progressing - whatever your ambitions. Purpose Statement: Responsible for leading the definition, design, and execution of system-level verification and validation strategies for complex medical device systems. ...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cepheid, 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. At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you ll get to make an immediate, measurable imp...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cepheid, 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. At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you ll get to make an immediate, measurable imp...

Additional Locations: India-Maharashtra, Pune Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we ll give you the opportunity to harness all that s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we ll help you in advancing your skills and career. Here, you ll be supported in progressing - whatever your ambitions. Purpose Statement: Responsible for leading the definition, design, and execution of system-level verification and validation strategies for complex medical device systems. ...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cepheid, 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. At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you ll get to make an immediate, measurable imp...

Additional Locations: India-Maharashtra, Pune Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we ll give you the opportunity to harness all that s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we ll help you in advancing your skills and career. Here, you ll be supported in progressing whatever your ambitions. Purpose Statement: Responsible for leading the definition, design, and execution of system-level verification and validation strategies for complex medical device systems. Th...

Looking for professionals with 5+ yrs exp in document control, QMS (ISO 13485), and change mgmt. Windchill PLM knowledge preferred. Engineering degree required. Immediate to 1-month joiners. sonali.tomar@saracasolutions.com

Job Description: Role Senior Audit Program Manager Experience 8 years of experience Qualification B E Computer Science or Information Technology Engineer Professional Competencies Mandatory ISO Standards CMMI High Maturity Practices Agile DevOps ISO 9001 ITSM CSM DevOps and relevant Industry Certifications around these competencies Preferred CMMI ISO 13485 AS9100D ISO 42001 in addition to above Mandatory Skills PMP Prince 2 CSPO Certified SAFe Agilist 5 0 Certifications can also apply Key Responsibilities: Skills Good knowledge of CMMI Model ISO 9001 standard ITIL practices Distributed Agile methodologies DevSecOps models Hands on experience in practicing and implementing Agile and DevOps pr...

Quality Engineer, PMS - Individual Contributor Reports to: Associate Manager, PMQ Trauma & Extremities 1.2 Roles and Responsibilities At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development. The Quality Engineer will work...

About Vantive Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will als...

Beckman Coulter LS Beckman Coulter Life Sciences mission is to empower those seeking answers to life s most important scientific and healthcare questions. With a legacy spanning 80+ years, we have long been a trusted partner to our customers, who are working to transform science and healthcare with the next groundbreaking discovery. As part of our team of more than 2,900 associates across 130 countries, you ll help drive our vision of accelerating answers and our commitment to excellence. Beckman Coulter Life Sciences is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we re pioneering the future of science and medicine, developing products that e...

Develop & maintain QMS documentation Ensure compliance with applicable quality standards and regulations Conduct internal audits & support external audits Work with CFT teams to resolve issues Train staff on QMS procedures

Review new and modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements. Capable of mentoring junior quality engineers in providing quality engineering support. Responsibilities may include the following and other duties may be assigned Review New Product Introduction (NPI) and Released Product Management (Released Products) documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements. Hands on experience with tools package release process for both Software & Hardware tools/accessories Review non product/off-th...

In this role, you will partner with cross functional team members to generate, analyze, communicate, and follow up on actions related to data analysis/ reporting for: -Field Corrective Actions administrative reconciliation -Service and Repair work order completion for capital correction and Software updates -Inventory management: loaner set tracking and return for inspection/ replenishment to the field -Other quality systems compliance duties (including data analytics) Responsibilities may include the following and other duties may be assigned Generates and analyzes reports (Field Corrective Actions, Product Hold Orders, Field Inventory) for compliance with KPIs, identification of patterns o...

Prepare and compile product post market data and findings into comprehensive Periodic Safety Update Reports (PSURs) in compliance with regulatory requirements. Serving as a mentor to junior engineers, providing guidance and support in quality engineering practices within the realm of medical devices. Responsibilities may include the following and other duties may be assigned Familiar with ISO 9001, ISO 13485, ISO 14971, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards. Good verbal and written communication skills including plan / report development. Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Devi...

KEY RESPONSIBILITIES: Delegating and directing service tasks, monitoring the progress of current projects, and managing service team members to ensure the team's objectives and sales goals are met. Handling customer complaints or concerns quickly and professionally to maintain good customer relationships and ensure repeat customers. Assisting with or performing administrative tasks, such as managing and updating invoices, processing new orders, and tracking inventory. Setting up and maintaining a service desk and evaluating its efficiency. Resolving service desk problems and improving service methods to increase the service desk's productivity and customer service. Monitoring department issu...

A Day in the Life Quality Engineer II for risk management & PSUR activities support for CST OU A Day in the Life Collaborating with cross-functional teams to develop comprehensive product risk management files, including the risk management plan, Hazard Analysis, DFMEA, and risk management report, adhering to ISO 14971 standards. Responsible for maintaining highest standards of product reliability and patient well-being through gather and analyze data, write reports, and communicate with regulatory agencies on ensuring product safety. Must Have Capability to conduct thorough reviews of new and modified product design documentation, assessing quality characteristics such as manufacturability,...

Description & Requirements Introduction: A Career at HARMAN Digital Transformation Solutions (DTS) We re a global, multi-disciplinary team that s putting the innovative power of technology to work and transforming tomorrow. At HARMAN DTS, you solve challenges by creating innovative solutions. Combine the physical and digital, making technology a more dynamic force to solve challenges and serve humanity s needs Work at the convergence of cross channel UX, cloud, insightful data, IoT and mobility Empower companies to create new digital business models, enter new markets, and improve customer experiences About the Role Bachelor s Degree in Engineering, Science or technical field with 4+ years o...

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. Job Description To support our extraordinary teams who build great products and contribute to our growth, we re looking to add an Engineer - Quality Compliance located in Bangalore. What a typical day looks like: Should develop and initiates standards and methods for inspection, testing and evaluation. Will be responsible to devise sampling procedures and designs and develops forms and instructions for recording, evaluating and reporting quality and reliability data. Will develop and implements methods and procedures for disposition of...

Job Description Summary Job Summary: The Product Safety and Standards Compliance Engineer will be responsible for ensuring that all medical devices and related products adhere to applicable safety standards and regulations. The role involves conducting thorough safety assessments, identifying potential hazards, collaborating with design teams to mitigate risks, and maintaining compliance throughout the product lifecycle. This position is crucial for prioritizing patient safety and ensuring regulatory adherence within the healthcare industry. . Job Description Key Responsibilities: Risk Assessment and Hazard Identification: Perform detailed safety analyses on new and existing medical devices ...

Role Description: We are seeking a Quality Assurance (QA) Manager to oversee and ensure compliance with quality standards, regulatory requirements, and Good Manufacturing Practices (GMP). The role requires strong expertise in Quality Management Systems (QMS), audits, and process improvements. Designation: QA Manager Department: Quality Assurance Experience: Minimum 7 years in Medical Device/Pharma/Life Sciences Industry Regulatory Experience: Minimum 3-5 years in ISO 13485, MDSAP, US FDA, GMP Compliance Industry/Background: Medical Device / Pharma / Lifesciences Industry Qualification: B. Pharm / M. Pharm / M.Sc. Life Science / B.Tech Biotechnology / Related Field Employment Status: Permanen...

Develop and execute the product strategy for Drug Delivery Single Use Bags and Devices. Work closely with R&D, regulatory, and sales teams to ensure successful product development. Conduct market analysis to identify opportunities for new products and improvements. Define product specifications, pricing, and positioning. Manage product lifecycle, from conception to commercialization. Oversee regulatory compliance and quality standards. Develop sales training materials and marketing strategies. Build relationships with key industry experts and healthcare professionals. Qualifications & Requirements: Bachelor s/Master s degree in Biomedical Engineering, Biotechnology, or Life Sciences. 5+ year...

We are seeking a Quality Control (QC) Manager to oversee product testing, quality analysis, and compliance with regulatory standards. The QC Manager will be responsible for ensuring the integrity of raw materials, in-process materials, and finished products. Designation: QC Manager Department: Quality Control Experience: Minimum 7 years in Medical Device/Pharma/Life Sciences Industry Regulatory Experience: Minimum 3-5 years in GMP, US FDA, ISO 13485, and Analytical Testing Industry/Background: Medical Device / Pharma / Lifesciences Industry Qualification: B. Pharm / M. Pharm / M.Sc. Life Science / B.Tech Biotechnology / Related Field Employment Status: Permanent Workplace Type: On-site Minim...

We are seeking a Design Engineer with a Mechanical Engineering background to work on product design and development. The ideal candidate should have expertise in SolidWorks and experience in designing components for the medical device, biotech, or life sciences industry. Designation: Design Engineer Department: Product Design & Development Experience: Minimum 2 years in design engineering Industry/Background: Mechanical / Medical Device / Pharma / Lifesciences Industry Software Expertise: SolidWorks (mandatory), AutoCAD (preferred) Qualification: B.E / B.Tech Mechanical Engineering or related field Employment Status: Permanent Workplace Type: On-site Minimum Requirements: Minimum 2 years of ...