50 Iso 14971 Jobs

Technical Writer (Medical Devices) Intern Location: Chennai IIT Madras Research Park (Onsite) Employment: Contract (6 months) with option to extend or convert to full?time Start: Immediate Salary: 10,000 per month Why this role Floaid is finalizing documentation for a new platform. We need a hands?on technical writer who can rapidly bring our User/Operator Manual , Service & Maintenance Manual , Installation & Commissioning Guide , and related controlled documents to release quality under a medical?device QMS. What you'll own (deliverables) Operator Manual (IFU): setup, priming, alarms, operating modes, UI walkthroughs, cleaning/sterilization, warnings/contraindications, symbol glossary (ISO...

Tips: Provide a summary of the role, what success in the position looks like, and how this role fits into the organization overall. Responsibilities Participate in the implementation and maintenance of the management system compliance with relevant international quality standards and regulatory requirements (Such as ISO 13485, ISO 14971, MDR 2017/745, and 21 CFR part 820). Participate in development of Regulatory Strategy for upcoming products against GSPR requirements. Participate in the development of QA strategies, recommendations for Continual improvement, Quality planning in conjunction with the needs of the company, for each product range and Quality Management System. Sustain and acti...

Define and implement reliability strategies and frameworks for software systems. Collaborate with cross-functional teams to integrate quality and reliability engineering throughout the SDLC. Lead risk management activities including DFMEA, hazard analysis, and traceability. Design and maintain post-market monitoring and alerting solutions to proactively address issues. Conduct root cause analysis and drive effective CAPA implementation. Develop tools and automation for reliability testing and validation. Ensure system availability through redundancy, failover, and recovery strategies. Support audits, regulatory inspections, and compliance with IEC 62304, ISO 13485, and ISO 14971. Mentor team...

Key Responsibilities: Assure compliance with software procedures and guide teams on development life cycle appropriateness Identify task dependencies and ensure effective development and maintenance efforts Lead both internal and external audits for software quality systems Provide training on ASP software quality engineering procedures to staff, contractors, and business partners Lead compliance and risk management activities for software or system projects Improve software quality processes based on industry trends and regulatory expectations Ensure compliant, reliable systems prioritizing patient safety are transferred to users Manage software change control in alignment with quality proc...

Key Responsibilities: Assure compliance with software procedures and guide teams on development life cycle appropriateness Identify task dependencies and ensure effective development and maintenance efforts Lead both internal and external audits for software quality systems Provide training on ASP software quality engineering procedures to staff, contractors, and business partners Lead compliance and risk management activities for software or system projects Improve software quality processes based on industry trends and regulatory expectations Ensure compliant, reliable systems prioritizing patient safety are transferred to users Manage software change control in alignment with quality proc...

Develop and maintain V&V strategy, plans, and protocols for ventilator systems in compliance with regulatory and quality standards. Define test methodologies for system-level, subsystem-level

• Develop and maintain risk management plans, procedures, and frameworks in compliance with ISO 14971. • Ensure risk management activities align with FDA 21 CFR Part 820.30 and ISO 13485 design control requirements.

Job Description Summary As directed by the Quality Manager, the Lead Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements. Works under general direction while independently determining and developing approaches to solutions. Frequent inter-organization contacts to achieve stat...

The Head of Regulatory Affairs will lead the regulatory function for Healthineers, Zone India, ensuring compliance with national and international regulations while supporting the company's strategic objectives. This role requires an experienced leader who can navigate the dynamic regulatory environment, advocate for the company's interests, and enable the successful registration, approval, and lifecycle management of medical devices in the Indian market. The individual will act as the primary point of contact with regulatory authorities, including the Central Drugs Standard Control Organization (CDSCO), and drive cross-functional collaboration to align business goals with regulatory require...

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 ...

Role & responsibilities • ISTQB Certification • Experience on product testing • Experience in smoke, stress, exploratory Testing • Experience in verification for medical products • Hands-on software enterprise application development experience • Exposure to ALM tool, Python • Knowledge of medical device software development is highly preferred including knowledge of standards such as IEC 62304, ISO 14971

OPENING FOR A WELL KNOWN OIL AND GAS COMPANY In INDIA: Position: Sr. Engineer/Assistant Manager Medical Testing Experience: 5 to 8 years of relevant experience in medical device testing , product safety testing, or compliance evaluation with Hands-on experience with IEC 60601 series standards and other medical device-related regulations Minimum Requirement: Bachelor's or Master's degree in Electrical Engineering, Electronics, Biomedical Engineering, or a related technical discipline. 4 to 8 years of relevant experience in medical device testing, product safety testing, or compliance evaluation. Hands-on experience with IEC 60601 series standards and other medical device-related regulations. ...

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...

Is catcher of PDLM subprojects from Product Industrialization Engineer for a specific technology To follow the good manufacturing practices (GMP). comprehension of DMR translation to production processes. Provides input for Manufacturing requirements in PDLM. To guide and perform PV related tests (e.g TMV, IQ, OQ & PQ) on the shop floor. Creates Quality Control Plan and Work Instructions Oversees equipment installation and supports rampup of specific processes at the site Gives input from factory side to the sign-off at SR milestone & project close Implements LCM design changes. Identifies and executes improvements in manufacturing processes, tools and equipment. This for quality and efficie...

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. PROGRAM MANAGEMENT CAREER STREAM: Program Managers and Directors focus on tactical, operational activities for a major program with broad or ongoing impact. Levels within the program management ca...

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 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. 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 mo...

Job Description Summary As directed by the Quality Manager, the Lead Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements. Works under general direction while independently determining and developing approaches to solutions. Frequent inter-organization contacts to achieve stat...

Job Description Help shape the future of healthcare by designing safe and intuitive image guided surgery and diagnostic imaging systems. As a Usability Designer, you will apply human factors and usability expertise to ensure Philips IGT products meet user needs and regulatory requirementsenabling clinicians to deliver faster, more effective care. Your role: Make a greater impact by improving the safety, usability, and effectiveness of our IGT systems, directly supporting better outcomes for patients and caregivers. Collaborate with cross-functional teamsincluding engineering, clinical, marketing, quality, regulatory, and serviceto deliver human-centered solutions that meet global medical dev...

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Responsibilities may include the following and other duties may be assigned. Lead and mentor cross-functional teams to develop comprehensive signal evaluation reports, product risk management files including risk management plans, Hazard Analysis, DFMEA, and risk management reports, adhering to ISO 14971 standards. Oversee the preparation and compilation of product post-market data and findings into comprehensive Periodic Safety Update...

JD for System Engineer provided by Philips team Primary Skills: typically 5+ Years of experience Bachelor's degree in Electronics or Electronics and Telecommunication. Experience: As a system engineer or in a similar role, with a strong understanding of system architecture and integration. Understanding and awareness of ISO 13485 and ISO 14971 standards, as well as CE certification and knowledge of FDA audits will be beneficial. Technical Skills: Proficiency in system design and development principles. Experience with various medical systems and system software, along with knowledge of LCM and NPI processes. Experience with X-ray systems will be beneficial. Problem-Solving: Strong analytical...

Job Title Design Quality Engineer - Medical Devices Job Description The Design Quality Engineer DQE provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met. The DQE also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes Your Role Ensure appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design Validate key design inputs like usability, reliability, performance, supportability, manufacturability, localizability...

Opportunity to work with a global medical equipment company Opportunity to take on a leadership role and contribute to the company's vision About Our Client Our client is a leading global medical technology company that provides innovative solutions in diagnostic and therapeutic imaging, laboratory diagnostics, and digital health services. Job Description The Successful Applicant Regulatory Strategy Development Define and drive the regulatory vision and strategy for CRM products, aligning with Healthineers business goals. Establish a roadmap for regulatory submissions, approvals, and compliance for new and existing product lines. Lead initiatives to address regulatory challenges in emerging ...

Bachelor's degree in a related field (e.g., Mechanical Engineering, Bio Medical) 8-10 years of work and project management experience, Leading or supporting the execution of Small to large-scale sustenance engineering projects like FCO (Field Change Orders) projects Strong Knowledge on ISO 13485, ISO 14971 and FDA- 21CFR 7, 21CFR 810 & 21CFR 806 Ensures to comply with QSR, ISO and Environment, HS requirements, as well as all applicable company procedures and policies Interacts and collaborates with other departments to solve any restriction that may stop or slow down process issues. Cross-Functional Collaboration: Facilitate cross-functional collaboration for remediation plan implementation,...

Role & responsibilities BE Mechanical Experience in medical device only Professional training and certification in in Quality Management Systems including ISO 13485 , Risk management ISO 14971, design assurance / control, verification and validation. • Sound understanding of medical device regulatory requirements for Class II and III medical devices. • Project planning resourcing, timelines, quality and budgets. • Skilled in implementing Quality tools like design of six sigma, risk management, FMEA, FTA (Fault Tree Analysis). • Preference for candidates with CQE certification or similar

About us We are Light Tree Ventures, a company specialized in Research, Development and Manufacturing of LED Light Therapy products for beauty and health. We have offices in the Netherlands, China, the US and India, with our headquarters in Rijswijk. Our team of professionals are the heart of our company and encompass a wide variety of cultures, skills and competences. We love our work and share the ambition to be the best at what we do : create meaningful, well-designed products for LED Light therapy markets worldwide. Light Tree Ventures (LTV) works with brands from all over the world. We develop custom light therapy devices that are being sold online and offline (in Sephora e.g.). This de...