215 Iso 13485 Jobs - Page 2

We are also Considering candidates Willing to Relocate - Job Location : Chennai Experience : 15 - 25 Years We are accepting Job Applications : Please submit updated CV - Email : [HIDDEN TEXT];[HIDDEN TEXT] Embedded Firmware Architect | Medical Devices | IEC 62304, IEC 60601 | Senior / Firmware Architect - Medical Devices | 10 - 20 Years | Job Description Responsibilities include - Design and architect embedded software systems from concept to production. - Lead and mentor a team of embedded software engineers. - Develop and maintain embedded software architectures and design patterns. - Optimize software for performance, reliability, and power consumption. - Conduct code reviews and ensure c...

Job Description Summary Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area. GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a dif...

Clinisys is a global provider of intelligent diagnostic informatics solutions and expertise designed to redefine the modern laboratory, across healthcare, life sciences, and public health. Millions of diagnostic results and data insights are generated every day using Clinisys platform and cloud-based solutions in over 4,000 laboratories across 39 countries. Our 1,450+ expert professionals, headquartered in Woking, UK and Tucson, Arizona, have a shared mission to enhance the effectiveness of diagnostic workflows in any laboratory or testing environment and keep citizens and communities healthier and safer. Role Description: This role is the quality owner of the product development and lifecyc...

Designation: Assistant Manager - Industry: IVD Industry - Korean Based MNC - Manesar Key Responsibilities: Operation & maintenance of HVAC, RO/DM Plant, DG sets, Compressors, and Boilers Cleanroom monitoring and utility documentation Ensuring compliance with ISO 13485 and GMP standards Coordination with QA and Production teams for utility support Qualification & Experience: B.Tech in Electrical Engineering 46 years of experience in utility operations and manufacturing setups. Interested Candidates share their cv Email : kshama.k@head2hire.com M: +91 7290007914 ( Voice & Whats app )

Our Client is seeking an experienced Vice President Manufacturing to lead high-precision manufacturing operations, drive innovation in medical device production , and ensure world-class operational efficiency . The ideal candidate will possess deep expertise in micro-precision components, electronics manufacturing, and regulatory compliance for medical devices . Key Responsibilities: Vice President Manufacturing (Medical Devices & Micro Precision Components) Location: Chennai Oragadam Factory Experience Required: 18 to 25 years Industry: Medical Devices, Micro Precision Components, Electronics Manufacturing Manufacturing Leadership: Oversee end-to-end manufacturing operations for medical dev...

Job Description Position: Executive Manufacturing Production Position Reports to: Associate Manager Manufacturing Downline Reporting: Associate Executives & Operators Location: Jigani, Bangalore, India Job Responsibilities To achieve Daily / Shift targeted production at required quality levels at specified costs in conformance with procedures specified in the quality system by ensuring availability of manpower, machines, and materials. To deliver products on time to the internal customers as per the production plan duly tying up suitable manpower requirement in the Department. To be Responsible for achieve the shift KPI factors such as, Labour Productivity, Optimum utilization of Consumables...

Hi, We have an urgent opening in MNC company for Quality Head-Pune location. Bachelors or masters degree in engineering, Quality Management, Environment Science, or a related field. 20+ years of progressive experience in quality , sustainability or EHS roles, preferably across multiple industries (e.g., automation, etc.). At least 5 years in leadership role in a multinational company. Strong knowledge of quality systems, compliance standards (ISO 9001, ISO 13485, ISO/TS 16949, GMP, etc.), and industry regulations. Certified Quality Professional (e.g., Six Sigma Black Belt, ASQ CQE/CQM/OE) is highly desirable. Demonstrated success in leading quality transformations, continuous improvement ini...

Job Title: Senior R&D Engineer Medical Devices Location: Mumbai, IND Employment type: Part-time Position Summary: We are seeking an experienced R&D Engineer Trainer with 10+ years in the medical device industry to lead the design, development, and optimization of innovative medical technologies. The role involves driving new product development (NPD) from concept through commercialization, ensuring compliance with global regulatory standards, and collaborating cross-functionally to deliver safe, effective, and high-quality medical devices that improve patient outcomes. Key Responsibilities: Lead the design and development of new medical devices, from feasibility studies through product launc...

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 Life Sciences, one of 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 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 automating...

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 HemoCue, 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. HemoCue is a leading provider of point-of-care diagnostic solutions, enabling healthcare practitioners across clinical settings and geographies to improve patient outcomes and clinical workflow...

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...

Job Title Health & Safety Officer - HIC- R&D Job Description Your role: Provides range of supporting activities to environment, health and safety team to ensure tasks are completed efficiently and effectively, exercising autonomy within established procedures. Performs periodic safety inspections, monitoring hazardous waste removal vendors, and may assist in consolidating hazardous wastes (chemical, radioactive, and/or medical). Maintains a detailed inventory of all safety equipment, tracking usage, maintenance schedules, and replacement dates to ensure that resources are always available and in optimal condition. Investigates workplace accidents and incidents, analyzing root causes, and pre...

Job Title Health & Safety Officer - Health Systems Job Description Your role: Provides range of supporting activities to environment, health and safety team to ensure tasks are completed efficiently and effectively, exercising autonomy within established procedures. Performs periodic safety inspections, monitoring hazardous waste removal vendors, and may assist in consolidating hazardous wastes (chemical, radioactive, and/or medical). Maintains a detailed inventory of all safety equipment, tracking usage, maintenance schedules, and replacement dates to ensure that resources are always available and in optimal condition. Investigates workplace accidents and incidents, analyzing root causes, a...

A Day in the Life Design Quality engineer for Tool packages to support Stealth station Careers that Change Lives This position is for design quality engineering support of software design and development of medical devices, stand-alone software of non-products, non-devices and components including firmware. Facilitate the application of design controls in product development and released product management. A Day in the Life 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 Must ...

A Day in the Life As a Engineering Manager working at Medtronic, you will be a leader contributing to the Software Verification and Validation functional area. This involves building and managing a highly engaged team of engineers to ensure that they are positioned for growth and success. Responsibilities may include the following and other duties may be assigned Lead a team of engineers of Software Verification and Validation Work closely with cross-functional teams, including design engineers, project managers, and quality assurance teams, to ensure seamless integration of verification and validation activities into the overall development process. Possess strong technical leadership skill...

Job Description Core Skills 15+ years of hands-on software development experience, with 3-5 years in a senior/principal architect role. Proven expertise in C# .NET and/or Java. Flexibility to work across both technologies is strongly preferred. Solid experience in backend architecture including system design patterns, cloud infrastructure, scalability, and reliability. Proficient in cloud-native architectures using AWS (preferred). Experience with Azure or GCP is a plus. Strong foundation in software design principles, design patterns, and clean architecture. Demonstrated experience designing and implementing complex, multi-generation software products. Deep understanding of Healthcare softw...

Job Description Job Title : Post Market Surveillance (PMS) Specialist The Post Market Surveillance (PMS) Specialist is a key member of the DXR Quality team and serves as a subject matter expert to support all aspects of Post-Market Surveillance. Key Responsibilities: The PMS Specialist is responsible for managing activities related to post-market product safety surveillance and risk management including: Creation and maintenance of PMS Plans Creation and maintenance of PMS Reports Conduct Periodic Quality Review Board Meetings and creation of Periodic Quality Review Reports Preparation and update of PSURs Audit and Inspection support Own and effectively drive CAPAs on post-market surveillanc...

Job Description Job Title : Post Market Surveillance (PMS) Specialist The Post Market Surveillance (PMS) Specialist is a key member of the DXR Quality team and serves as a subject matter expert to support all aspects of Post-Market Surveillance. Key Responsibilities: The PMS Specialist is responsible for managing activities related to post-market product safety surveillance and risk management including: Creation and maintenance of PMS Plans Creation and maintenance of PMS Reports Conduct Periodic Quality Review Board Meetings and creation of Periodic Quality Review Reports Preparation and update of PSURs Audit and Inspection support Own and effectively drive CAPAs on post-market surveillanc...

Job Description Job title: You are a part ofu00A0the Ultrasound R&D team - Pune. Philips HIC, Pune, is playing a key role in Philips global strategy for Ultrasound. With Philips HIC, the foundation was laid to touch billions of lives and reiterate Philips commitment towards Indian and growth healthcare markets. Your role: Defining, for products to be developed, the applicable safety standards and regulations such as IEC 60601 series and/or IEC 62304, IEC 62366, the new EU MDR, and Particular Standards IEC60601-2-37, and in particular EMI/EMC IEC 60601-1-2 standards and testing Defining within the Standards and Compliance plan how the required standards and regulations will be covered in evid...

The Opportunity: Avantor is looking for Q&R Systems Specialist who Works independently under close supervision, work closely with various departments to perform and validate test cases based on quality requirements, and recommend changes to predetermined quality guidelines. Responsible for ensuring that the end product meets the minimum quality standards, is fully functional and user-friendly. Interpret and implement quality assurance standards and provide accurate and comprehensive feedback to colleagues. Develop and execute test plans to ensure that all objectives are met. Implement and monitor test scripts to assess functionality, reliability, performance, and quality of the service or pr...

The Opportunity: . The Opportunity: Ensure uninterrupted product manufacturing by executing production activities aligned with established quality and operational standards. Drive consistency and efficiency through adherence to defined procedures and responsibilities. What we are looking for: Experience: Min 05-06 years of Exp of relevant experience Educational Qualification : Postgraduate or above in Sciences - Life Science /Biotechnology Microbiology/Chemistry /Pharmacy. Manage the workforce for manufacturing of IVD products manufacture at Dehradun plant through a staff of both professionals and contract labor. Supervision of assigned work/operations of Rapid/ELISA/Biochemistry/Hematology ...

JOB DESCRIPTION: Job Title: Regulatory Affairs Specialist - Medical Devices Location: New Delhi Department: Regulatory Affairs Reports To: Regulatory Affairs Manager Job Summary: The Regulatory Affairs Specialist is responsible for ensuring that medical devices comply with all applicable regulations in India and international markets. This role involves preparing and submitting regulatory documents, maintaining compliance with CDSCO and other global regulatory bodies, and supporting product development teams with regulatory guidance. Key Responsibilities: Prepare, compile, and submit regulatory dossiers for product registrations, renewals, and amendments to CDSCO and other regulatory authori...