20 Iso13485 Jobs

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...

JOB RESPONSIBILITIES OF PRODUCTION MANAGER Location: Delhi/ Faridabad Purpose of the Position :- The purpose of this position is to ensure that production planning , monitoring is done timely and executed efficiently. Ensure that proper documentation is maintained as per laid down SOPs / Regulatory requirements and ISO Guidelines Job responsibilities 1. Production Planning & Execution Develop and execute daily, weekly, and monthly production schedules. Ensure optimal resource allocation (manpower, machines, material). Coordinate with procurement, QA/QC, and warehouse teams. 2. Compliance & Quality Assurance Ensure production processes comply with ISO 13485, and regulatory requirements (e.g.,...

Role & responsibilities QA Documents Preparation, review, & revision (such as Work Instructions, Flowcharts, SOPs, Inward Quality Plan, Technical Data Sheet, Formats, etc.) Document Control (Soft copy & Hard copy) Coordinate with QC, Production, Design team & management. Maintain master copy & distribute control copy of documents to respective departments. Gain knowledge regarding medical device applications. Developing and implementing quality systems: Including policies, procedures, and guidelines, to ensure that products or services meet the required quality standards. Conducting audits and monitoring processes to ensure that they comply with quality systems and standards. Handling Custom...

Job Description Job title: Quality Engineer, Products and Systems Your role: Be part of Project team and participate in defining product design input, requirements, V&V, output and design transfer requirements and plans. Ensure product quality, compliance and state of art throughout the product lifecycle. Reaffirm that design input are transferred to product design and verified to confirm that design output meet the design input. In collaboration with multi-disciplinary team, lead the design for reliability to create a reliability plan and include the reliability requirements in product design. Ensure that reliability requirements are met through test, verification and validations, as applic...

#Hiring Regulatory Affairs Manager for one of the reputed MNC into Healthcare industry. Position Title: Regulatory Affairs Manager Location: Gurugram About Role:- The Regulatory Affairs Manager will be responsible for managing the regulatory strategy and ensuring the compliance of medical devices/IVD with applicable regulations. The candidate should have relevant years of experience in Regulatory Affairs. Preferably, complete knowledge of Indian Regulatory Requirements with in-depth understanding of D&C Act, MDR 2017& BIS. This role involves working closely with cross functional team. The manager will monitor regulatory changes, support product submissions, and ensure timely approvals to mai...

Role & responsibilities Product Industrialization Engineer - Medical Devices Knowledge on medical product life cycle management Should understand manufacturing fundamentals Responsible for PDLM-Driven design changes at manufacturing facility and at supplier Accountable for Manufacturing-BOM and routing master data until release to shipment and their implementation Accountable for establishing inspection and test criteria for components and assemblies Evaluate NPI related engineering changes To be responsible for Engineering Change Request activities. Supplier communication to create samples for NPD parts and verify supplier reports. Create new part numbers and do FAI plans based on drawings ...