30 Iso13485 Jobs

About the Role We are seeking a SaMD QMS & Regulatory Expert to lead quality and regulatory activities with a specific focus on FDA compliance and IEC 62304 software lifecycle management. This role is central to ensuring that our Software as a Medical Device (SaMD) products meets all applicable U.S. FDA regulatory requirements while maintaining a robust, software-driven Quality Management System (QMS) that aligns with ISO 13485, ISO 14971 and FDAs requirements. The ideal candidate will have deep expertise in software lifecycle documentation, design controls, risk management, verification/validation, and regulatory submissions for software-based medical devices. The person should be someone w...

Role Overview: You will be responsible for maintaining Quality Standards by inspecting incoming parts from suppliers for in-process FAI Production/R & D/Production of finished products and recording compliant quality results. As a part of Varex Imaging, a leading innovator in X-ray imaging component solutions, you will play a crucial role in ensuring the quality of X-ray tubes, digital flat panel detectors, software, and other key components of X-ray imaging systems. Key Responsibilities: - Perform In-Process and Final Inspection on Parts/Materials. - Interpret and apply GD&T (Geometric Dimensioning and Tolerancing) to validate parts. - Prepare and Record Compliant First Article Inspection R...

Responsibilities: Develop & implement quality systems using ISO13485, Six Sigma Green Belt, ISO9001. Conduct audits, manage CAPAs, ensure FDA/QSR/MDR compliance. Work closely with R&D for (NPI) to ensure quality planning (DFMEA, PFMEA, Control Plan)

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career You just found it. Job Overview Head of Quality and Regulatory Compliance is responsible for leading the Quality and Compliance Groups for the India Innovation Center (IIC) in Bangalore, India. The position will be required to participate on the leadership team of Getinge India. This position is responsible f...

Choosing Capgemini means choosing a place where you'll be empowered to shape your career, supported by a collaborative global community, and inspired to reimagine what's possible. Join us in helping leading Consumer Products and Retail Services (CPRS) organizations unlock the value of technology and drive scalable, sustainable growth. Your Role As a Quality Manager / Quality Analyst , you will play a key role in driving quality excellence across projects and business units. You will be responsible for implementing and maintaining Quality Management Systems, conducting audits, analyzing metrics, and ensuring compliance with industry standards. Your expertise will help teams deliver high-quali...

Education / Experience: Graduate in Mechanical or Electrical Engineering 10+ years in managing and maintaining Mechanical/Electrical/Chemical Labs Proficient in supporting test execution, fixture building and prototype support. Duties and Responsibilities Include: Direct oversight and management of the labs that includes incoming, in-process, and release testing. Ensures the lab is functioning appropriately (e.g. maintain proper inventory levels of lab supplies, proper maintenance, and calibration of equipment, AMCs of equipment, proper scheduling of Lab staff to meet business needs, etc.) Asset tracking and maintenance of the records as per the Quality and Regulatory requirements of the Org...

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...

As a Lab Manager, your role involves overseeing and managing Mechanical, Electrical, and Chemical labs. Your key responsibilities include: - Direct oversight of incoming, in-process, and release testing in the labs. - Ensuring proper functioning of the labs by maintaining inventory levels of supplies, equipment maintenance and calibration, scheduling lab staff, and managing equipment AMCs. - Tracking assets and maintaining records as per Quality and Regulatory requirements. - Providing supervision and direction to employees, ensuring proper training on testing and methodologies. - Contributing to the development, updating, and review of Test Procedures, SOPs, and Protocols. - Performing trou...

Role Overview: As a Regulatory Compliance Manager at CareNX, located in Mumbai, you will play a crucial role in ensuring the company's adherence to regulatory requirements and standards. Your responsibilities will include monitoring and analyzing regulatory changes, managing regulatory affairs, and ensuring compliance in all operational activities. You will collaborate closely with the finance team to guarantee regulatory compliance in financial practices. Key Responsibilities: - Monitor and analyze regulatory changes relevant to the healthcare industry - Manage regulatory affairs to ensure adherence to standards like ISO13485, IEC, CDSCO, CE, and FDA - Ensure compliance in all operational a...

Job Description Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow. But itu2019s not just what we do, itu2019s who we are. We are 80,000, wonderfully unique individuals, with two things in common. and a relentless determination to deliver on our customersu2019 needs. Itu2019s what inspires us to create meaningful solutions u2013 the kind that make a real difference u2013 when it matters most. The world and our customersu2019 needs are changing faster than ever before and while we are proud of what we do already, we know w...

Experience: 5+ years Qualification: Bachelors Degree in Mechanical Engineering / Biomedical Engineering / Industrial Production Job Description: 1. Manpower handling and management. 2. Extrusion tubing, insert and injection molding, micro-molding grade plastics. 3. Clean room operation (Class 100k to class 10k) 4. Vendor & Quality management, developing long term contracts with polymers suppliers and mold makers. 5. Regular vendor audits for quality consistency. 6. Ability to read and interpret product drawings and tolerance. 7. Familiarity with medical grade polymers. 8. Understanding of GMP & ISO 13485. 9. Basic knowledge of bio-compatibility standard (USP Class VI, ISO 10933). 10. Product...

Project Manager for medical device development Phillips-Medisize, a Molex company, is looking for an experienced Project Manager for Global Innovation Development in Bangalore, India. If you are interested in being part of a project organization and passionate about creating unique products for people who need medical treatment it might be you, we are looking for. About The Position You will be leading cross functional development projects, delivering new medical devices to our global pharma customers with focus on customer requirements and business value. As a Project Manager you are part of scoping the projects in the contractual agreements and you establish and align deliveries with the c...

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. ...

Join a team that values innovation, growth, and impactful work. Don't miss the chance to work with cutting-edge projects in SME and be a part of something transformative! Drive Date: 26th July Saturday (9AM-2PM) Skills Required: - Experience in DHF remediation - Proficiency in Design Control, Design Verification, and Design Validation - Expertise in WindchillPLM in the medical domain Venue Location: HCLTech Elcot Sez, New Cafeteria 2nd Floor, 602/3, 138, Medavakkam High Road, Sholinganallur, Chennai-600119 Position: Mechanical Design (Lead, Technical Lead) Experience: 2.5-10 years Job Location: Chennai Job Description: - B.E / B.Tech or higher education in Mechanical Engineering - Sustaining...

As a Lead QMS at Ai Health Highway, you will play a crucial role in implementing Quality Management System (QMS), ISO13485, EU MDR, and US FDA (510k) Risk Management processes for our cutting-edge medical devices. Your responsibilities will include creating device master records, updating technical documentation, and collaborating with internal and external stakeholders to establish a robust quality management and regulatory framework for our product pipeline. You will work closely with engineering and manufacturing teams to develop verification test strategies to ensure the safety and reliability of our products. Additionally, you will be involved in developing product requirements, support...

As the Head of Quality and Regulatory Compliance at the India Innovation Center (IIC) in Bangalore, India, you will play a crucial role in leading the Quality and Compliance Groups within the organization. Reporting to the Supervisor Director Quality and Compliance Critical Care, you will be an integral part of the leadership team at Getinge India. Your primary responsibility will be to ensure the effective establishment and maintenance of quality systems in the projects executed at IIC. You will be tasked with providing strategic leadership and management for the Quality Systems at the IIC, developing a competent and accountable Quality organization aligned with business objectives and comp...

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). Impacts quality of own work and the work of others on the team. Focused on execution of standard enabling activities/provision of advice subject to policy and work routines within an enabling discipline. There may be some latitude to rearrange the sequence to complete task/duties based on changing situations. Job Description Roles and Responsibilities Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes...

We are looking for a Sr. Product Owner to join our Program and Portfolio Team and work on our next-generation patient engagement and management solutions. At Philips Sleep and Respiratory Care, we aim to make people sleep and breathe easy through innovative sleep/respiratory therapy devices, patient interfaces and medical-grade artificial intelligence and cloud technology solutions. Our flagship product, the Care Orchestrator, DreamMapper, Sleepware, and MaskSelector solutions, are leading software for patient engagement and management solutions in the patient's sleep therapy journey. Our customer base spans to more than 65 countries globally and serve millions of patients. We are currently ...

You will be responsible for Mechanical design in the field of Medical Devices, with a focus on Medical Device Design Controls, Design Verification, and Validation processes. A minimum of 3 to 5 years of relevant experience is required for this role. As a Sustaining Engineer, you will lead Change Qualification projects for medical devices, collaborating with a diverse Cross-Functional Team. Your tasks will include developing test protocols, ensuring the quality of deliverables, and managing risk through proactive identification and mitigation planning. Proficiency in DesignControl process for Medical Devices is essential, along with expertise in Mechanical Engineering basics. You should posse...

Role & responsibilities Job Description/Roles & Responsibilities Job Summary Hardware Developer who is ready to lead the Hardware design team, work on new circuit design and developement for products that can cure complications in new-borns, especially who need assistance just after birth. Knowledge of microcontroller based hardware design, sensors relating to flow, temperature and good EMI/EMC compliance relating to medical devices is a must for this position. Responsibilities and Duties Technical collaboration between the cross functional team and the client. Compile and analyze customer requirements, work with the team to find solutions, and consolidate and analyze customer requirements. ...

As a Medical Mechanical Design Verification/Control Engineer at HCLTech in Chennai Shollinganallur, you will be joining a team that values innovation, growth, and impactful work. This is an opportunity to work on cutting-edge projects in SME and be a part of something transformative! The walk-in drive is scheduled for 21st July Saturday from 9AM to 2PM at HCLTech Elcot Sez, 602/3, 138, Medavakkam High Road, Sholinganallur, Chennai-600119. The position available is for Mechanical Design (Lead, Technical Lead /Sr Lead) with an experience requirement of 3-7 years. To be eligible for this role, you should have a B.E/B.Tech or higher education in Mechanical Engineering. Sustaining Engineers are e...

Responsibilities: Ensure product compliance with ISO standards through quality testing. Collaborate on design reviews and risk assessments. Develop test plans, execute tests, analyze results. Experience with FDA & ISO13485 & PCB design, CAD/CAE s/w.

Key Responsibilities: Administer document and record control systems, ensuring version control, traceability, timely reviews, and overall compliance. Perform and document software tool validations and revalidations, ensuring alignment with relevant standards. Support supplier selection and ongoing monitoring, including maintaining relevant documentation and ensuring supplier compliance. Monitor regulatory developments (e.g. AI Act, GDPR), assess gaps, and implement required changes in the QMS. Draft, revise, and maintain procedures and work instructions based on regulatory or process changes. Prepare input for periodic management reviews, including KPIs, audit outcomes, and improvement actio...

You will be responsible for embedded hardware design with a focus on digital circuits. Your key responsibilities will include: - Developing new hardware solutions from initial requirements through prototypes to production-ready. - Designing embedded circuits, including component selection, Spice simulation, control loop design, power supplies, signal integrity check, interface designs, protocol analysis, mechanical interference, thermal analysis, high-reliability, long availability, BOM management, etc. - Coordinating with Layout engineers for proper layout design inclusive of power supplies routing, signal integrity, thermal dissipation, clear documentation, etc. - Maintaining existing desi...

Role & responsibilities Responsible for development, implementation, maintenance, and overall success of the companys quality and regulatory programs and strategies, including articulating quality standards and objectives, developing methods to embed quality into the product development and manufacturing processes, establishing vendor relationships and quality standards, and developing and implementing innovative programs to focus employees on improving product quality. Develop, implement, and support a comprehensive regulatory compliance strategy to meet global market requirements for our products and ensure alignment with our overall business strategy. Proactively partner with R&D, Marketi...