309 Iso 13485 Jobs - Page 10

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. . Job Description Roles and Responsibilities GEHC ONLY Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality met...

ql-editor "> Head, Lateral Flow Assay (LFA) Team Roles & Responsibilities Direct the end-to-end development of quantitative/qualitative lateral flow assays (LFAs) with a strong emphasis on colloidal gold-based technologies, from concept through commercial launch. Develop and implement project plans, ensuring timely delivery of milestones and final products to the commercial market. Build, mentor, and manage a multidisciplinary team of scientists, engineers, and technicians; foster a collaborative environment that encourages innovation and professional growth. Coordinate with manufacturing, quality assurance, and regulatory teams to ensure robust assay design, process optimization, and regula...

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...

Strong knowledge of FDA QSR, ISO 13485, EUMDR & regulatory norms. Manage QMS docs, DHFs, CAPAs, audits, suppliers, training & calibration. Support audits, product dev, quality improvements & regulatory compliance. Excellent doc & comm skills needed.QMS Management: Take ownership of QMS documentation, ensuring it's current, accurate, and accessible. Regulatory Compliance: Apply strong knowledge of FDA Quality System Regulation (QSR), ISO 13485, and EU Medical Device Regulation (EUMDR) to all quality processes. Design History Files (DHFs): Manage and maintain Design History Files, ensuring completeness and compliance throughout the product development lifecycle. CAPA Management: Lead and suppo...

Electronics Engineer Medical Device Product Development Location: Pune, Maharashtra, India Employment Type: Full-Time Experience Required: 57 years About InnoIQ Engineering InnoIQ Engineering, a subsidiary of B&W Engineering und Datensysteme GmbH (Germany), excels in research, design, and development of precision medical devices. From concept through regulatory compliance and production support, we deliver innovative, high-quality solutions for global clients in the medical device space. Role Overview As a key member of our team, youll lead electronics design for new medical devicesfrom schematic capture and PCB layout using Altium Designer , to component selection and prototype validation. ...

Job Title: Embedded Software Engineer Medical Device Technology Location: Pune Department: Engineering / Embedded Systems Employment Type: Full Time Company Overview: InnoIQ Engineering , a subsidiary of B&W Engineering und Datensysteme GmbH, Germany , is a leading company specializing in the research, design, and development of innovative medical devices . With a strong focus on precision, quality, and customer-centric solutions , we collaborate with global clients to bring advanced medical technologies to life. From concept design and prototyping to production support , we offer comprehensive engineering solutions tailored for the medical device industry . Position Summary: We are seeking ...

Key Deliverables: Provide quality oversight across design, validation, and lifecycle of combination products Support regulatory submissions, audits, and RTQ responses Ensure compliance with global standards including ISO 13485 and 21 CFR Lead quality process improvements for device, labeling, and packaging Role Responsibilities: Act as single point of quality contact for final product activities Review risk management, HFE documentation, and design controls Train teams on quality and regulatory requirements for combination products Manage complaint investigations and site transfer quality activities

Job Purpose: Maintain compliance to Quality Management System to deliver consistent quality medical devices to fulfil future strategy of Cipla. To Lead and establish Quality Management System for medical devices as per EU Regulatory requirements, CDSCO and ISO 13485 requirements and develop and implement documentation such as SOPs, Quality manual etc. to define the framework. Monitor effective implementation of Quality System across function and appraise Management Representative. Responsible for monitoring metrics/KPI for medical devices starting from design, manufacturing, postproduction. Compile data for management review meetings. Responsible for coordinating with cross functional team f...

Education : Minimum B.Sc./M.Sc./B. Tech with computer operating Knowledge. Key skills: Knowledge of Medical Device Industries, ISO, CE & Indian Medical device Rules 2017(Drug department). Responsibility : Deep knowledge of ISO 13485 and ability to make necessary modifications as per requirements. Knowledge of EUMDR, Indian MDR and applicable government regulations. Responsible for regulatory affairs activities to assist in regulatory submission. Responsible for Risk Management as per ISO 14971. Responsible for customer complaints and in-house nonconformity. To conduct and maintain records of Internal audits and MRM including quality objectives. To prepare process validation protocol and perf...

Education : UG: B Tech in Mechanical, BSc, B. Tech Medical Science, M sc. Key skills: Regulatory Submissions : 510(k), CE Marking, EU MDR 2017/745, US FDA, Indian MDR 2017 Clinical Evaluation Reports (CER) : Development, Literature Reviews, Clinical Data Analysis Risk Management : ISO 14971, Risk Assessments, Risk Mitigation Strategies Post Market Surveillance (PMS) : Data Collection, Reporting, Device Performance Monitoring Post Market Clinical Follow-up (PMCF) : Study Design, Data Analysis, Reporting Regulatory Compliance : US FDA, EU MDR, Indian MDR, ISO 13485 Communication : Cross-functional collaboration, technical writing, regulatory guidance Desired Candidate Profile: Regulatory Affai...

To apply to a Varex Imaging position, please create an account and sign-in. CURRENT VAREX IMAGING EMPLOYEES: Please apply by logging into your internal Workday Account . Summary Performs product inspection and/or audits of quality control programs. Performs packaging line and manufacturing inspections, and sampling and testing of incoming components and raw materials. Ensures raw materials, in-process and finished products meet company standards. May apply approval or rejection labels to bulk raw materials once analytical data is evaluated. May draft procedures and assist with validating or troubleshooting testing methods, including assays. May assess draft and final label copy, using knowle...

Working knowledge of relevant global medical device regulations, requirements, and standards, such as ISO 13485, 21 CFR Parts 803, 806, and 820, ISO 14971, the European Medical Device Directive (93/42/EEC), and EU MDR (2017/745). Provide Quality and Regulatory Affairs input to the product development team and manage all QA & RA responsibilities throughout product development, design changes, and post-market surveillance processes. Establish and analyze key performance indicators to evaluate and continuously improve the Quality Management System (QMS). Possess broad experience and apply professional concepts and company objectives to resolve complex issues in creative and effective ways. Prov...

Role & responsibilities Inspection - release/rejection of incoming material against approved specification. Rejection of material non conformance review, reporting in IMSxpress. Updation of critical incoming material list (incoming material specification) based. Allocation of catalogue number to finished products depending on customization/changes in product. Control of documents (QSP, SOP, formats, MFR, MQR) issuance, retrival, archival and updation in IMSxpress. Compiling of data for MIS as per schedule Allocation of batches as per customer purchase order over mail. Review of certificate of analysis for finished products. Daily IPQA of production and BMF as per the approved protocols and p...

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 GEHC ONLY Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsibl...

As a Principal Project Management Specialist, you will be a key member of the Medtronic Quality Engineering team responsible for maintaining the highest standards of product reliability and patient we'll-being across the Cranial and Spinal Technologies (CST) Operating Unit. CST provides a comprehensive portfolio of proven powerful technologies setting the highest standards of integrity and reliability in Cranial and Spinal care. Responsibilities may include the following and other duties may be assigned Responsible for planning, initiating, monitoring, tracking and/or prioritizing MEIC Quality engineering teams programs and facilitating successful, on-time and within budget execution. Sets c...

Job Title Manufacturing - PIE - STET Job Description Job title: Manufacturing -PIE - STET Job Location: Chakan. The primary function of this role is to execute Manufacturing Engineering activities through high-quality process verification and validation, sustain and improve manufacturing systems processes, tools, and equipment to ensure predictable, reliable, stable, and efficient production, support troubleshooting and product industrialization, drive innovative process validation to improve quality and reduce costs, lead technical aspects of product development through manufacturing release, manage the transition of products from engineering to manufacturing, sustain various devices follow...

Role & responsibilities Responsible For Assisting Audit, Quality Manager and MR In Implementing Goals, Objectives,, Policies, Procedures and Systems Pertaining to the Quality Control and Regulatory Functions Responsible For Assisting Audit, Quality Manager and MR for Documentation Related to Quality System Guidelines Assisting In Implementing & Documenting for Iso Processes

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. Job Description Roles and Responsibilities Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensure...

Hiring QA & RA with an leading IVD Company in Hyderabad Exp: 6+ Yrs in QA & RA, ISO 13485 Mandatory Stability & immediate joiner with Biotech background Candidate With medical Device background can apply share resume at sarika.bhandari@acumont.com

PURPOSE AND RESPONSIBILITIES OF THE POSITION Carry out audits at suppliers in accordance with the reference regulations, Eurofins Sisthema procedures and specific customer requests. Draft audit reports within agreed timelines. DESCRIPTION OF THE ACTIVITIES Macro Areas of Activity Pre-audit Management of pre-audit documents Preparation of the audit agenda Collaboration in travel preparation Audit Conducting the audit Post-audit Drafting of audit reports and audit comments. Drafting amended documents following customer request Evaluation of the CAPA plan CROSS-FUNCTIONAL (INTERNAL AND ETERNAL) RELATIONS Roles and Areas with which links are held Customer Preparation of the audit agenda, draftin...

Why join AliveCor ? At AliveCor, we imagine a healthier world powered by access to personalised intelligent information. Were on a mission to be the world s heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical ECG devices and continues to lead the way in empowering consumers and patients to take care of their heart. Using our FDA-cleared medical-grade hardware and software, millions of users have taken more than 200 million heart health measurements and counting. Our vibrant team of people are attracted to AliveCor because they want to build something meaningful -- and AliveCor delivers: every day, customers tell us that ...

Objectives of this role Design and develop hardware products, including circuit boards, components, and systems, while adhering to industry standards and best practices. Generate and maintain hardware design, testing, and quality control documentation. Participate in design reviews, risk assessments, and product validation activities to ensure compliance with regulations. Collaborate with cross-functional teams, including design, development and customer support, to provide feedback and input on product design, performance optimisation, and manufacturability. Your tasks Conduct thorough testing and validation of hardware products to ensure compliance with specifications, requirements and qua...

Your Tasks Responsibilities: Plan and execute product risk management activities together with the project management in an agile development. Work with cross functional teams to identify and evaluate potential safety risks and develop risk mitigation measures for hazardous situations which could occur in the use of the medical devices, health software products and components. Track the implementation of mitigations in close collaboration with product development teams to ensure the effectiveness of the risk control measures. Analyze various industry and regulatory sources of information for potentially applicable risks. Participate in the development and review of the product design inputs ...

Experience Key Responsibilities: Hands-on experience in aseptic processing of biological/pharma products, including sterile filling, sealing, and packaging. Skilled in operating aseptic equipment and ensuring compliance with GMP, GDP, ISO 13485, and Health Safety standards. Maintains strict hygiene protocols and controlled sterile environments. Proficient in environmental monitoring, aseptic area upkeep, and contamination control. Accurate documentation of batch records, QC logs, and processing reports. Strong foundation in microbiology and pharmaceutical standards, backed by B.Sc./M.Sc./B.Pharm/DMLT qualifications. 1-4 years of industry experience in aseptic manufacturing and sterilization.

Hiring Production Supervisor for a Medical Device Manufacturing company Job Title: Production Supervisor Medical Devices Location: Bengaluru Experience: 5 - 8 Years Department: Manufacturing / Operations Summary of the role: We are seeking a detail-oriented and proactive Production Supervisor to oversee the manufacturing operations of medical devices , with a specific focus on the X-ray tube production line . The role demands strong leadership, technical expertise in high-voltage components, vacuum processing, and precision assembly within cleanroom environments. The ideal candidate will ensure production efficiency, safety, and compliance with ISO 13485 , FDA 21 CFR Part 820 , and Good Manu...