309 Iso 13485 Jobs - Page 7

Bachelors degree in Life Sciences, Engineering, or a related field. 3-5 years of experience in QA roles with strong focus ondocumentation and compliance in the medical device industry. In-depth knowledge of ISO 13485, FDA QSR, EU MDR, and risk management (ISO 14971). Proven experience with QMS documentation management and inspection/audit readiness. Familiarity with risk management tools (e.g., FMEA, Hazard Analysis). Strong attention to detail and high standards for documentation accuracy. Experience in a startup or fast-paced, resource constrained environment preferred. Excellent written and verbal communication skills. Preferred Qualifications: Certified Quality Auditor (CQA), Six Sigma, ...

Lead and oversee all daily manufacturing activities, ensuring production targets, t imelines, and quality standards are met. Develop and implement effective production strategies aligned with company goals. Ensure full compliance with regulatory and quality standards, including ISO 13485, FDA 21 CFR Part 820, and EU MDR. Manage cleanroom operations and ensure adherence to safety and hygiene protocols. Plan and optimize resource allocation including manpower, materials, and machines. Implement and promote Lean Manufacturing, 5S, Six Sigma, and other process improvement techniques. Coordinate with cross-functional teams such as Quality, R&D, Regulatory Affairs, SCM, and Maintenance. Oversee pr...

Looking for Quality NPI Engineer for gurgaon location.

The team developing industry leading X-ray generation subsystems is looking for highly motivated regulatory engineers to join them in ensuring compliance and availability of these subsystems for CT scanners to all the global markets of interest. Regulatory Engineer will be working on compliance activities for various medical devices global regulations. Responsibilities Collaborate with cross functional teams (engineering, manufacturing, regulatory, sourcing, etc.) to lead or support compliance activities to medical device regulations. Review regulatory compliance change notifications and drive associated actions to be compliant by the effective date Lead compliance efforts to various global ...

Perform registration dossier for all the Life Science Products in all countries (except USA) Participate to gathering the technical documentation for new product development Maintain the adequacy with the regulation for technical documentation Product lifecycle management: Support product design changes, labeling updates, sustainment, and improvement activities from regulatory perspective. Assess regulatory impact, develop detailed action plan to drive regulatory compliance and ensure on time completion of identified actions. The essential requirements of the job include: A Bachelor s degree in areas of life sciences or engineering field with a minimum of 8 10 years experience in a regulated...

Responsibilities: * Manage QMS implementation & maintenance * Conduct process audits & ISO audits * Develop & implement quality strategies * Collaborate with cross-functional teams on improvement initiatives

Role & responsibilities Job Description -Software Quality Engineer (QA/RA) Design, develop, and optimize high-performance SAMD applications using SIMD for real-time. Ensure all software development complies with regulatory standards such as IEC 62304, ISO 13485, FDA 21 CFR Part 820, and EU MDR. Collaborate with cross-functional teams (RA/QA, Software/firmware development, and R&D teams) to ensure the software meets safety and performance requirements. Create and maintain documentation such as SDLC deliverables, Risk management files, Verification and Validation protocols, Usability, and Cybersecurity deliverables. Participate in internal audits, regulatory submissions, and post-market survei...

Role & responsibilities Design and manage electrical distribution systems for both maintenance and new projects based on load requirements. Able to handle compliances with Pollution Control Board norms and other regulatory guidelines. Support the companys energy management, sustainability, and net-zero initiatives. Capable to handle troubleshoot and PLC based manufacturing machinery. Maintain and update ISO 13485 documentation related to maintenance activities. Oversee and enforce safety compliance across all maintenance operations. Prepare and update plant layouts using AutoCAD as and when required. Maintain accurate asset management records. Able to handle daily routine complains and take ...

Role & responsibilities: : Develop, write, and maintain clear and concise Work Instructions for production processes based on engineering specifications, process validations, and manufacturing requirements. Collaborate closely with cross-functional teams including Engineering, Quality, and Production to gather information and ensure documentation reflects current best practices Ensure all documentation complies with applicable regulatory and quality system standards (FDA, ISO 13485, etc.). Format documents according to internal templates and document control requirements. Participate in document reviews, revisions, and approvals using the company's document control system. Support continuous...

At Ascent Meditech , quality isnt just a checkpoint its a commitment stitched into every support belt, sealed into every wound-care product, and engineered into every mobility aid we craft. As the custodians of Flamingo , one of Indias most trusted medical device brands, were looking for a Head Quality Control who believes defects are not errors they are missed opportunities to protect trust. Whats the Mission To lead from the front in our journey toward zero-defect manufacturing , robust supplier performance, and world-class product reliability across orthopaedic supports, healthcare essentials, wound & injury care, and mobility solutions. Your Toolbox Should Include: 1.1218 years in Medica...

About OptraSCAN: We are a fast-growing health-tech company focused on building AI-enabled digital pathology solutions that are used by hospitals, laboratories, CROs, and pharma companies in over 30 countries. Our mission is to make precision diagnostics more accessible, efficient, and intelligent. With OptraSCAN , transitioning from conventional microscopy to digital pathology becomes seamless. Our solutions enable effective acquisition of whole slide images, along with features such as viewing, storing, archiving, real-time sharing, and reporting. We offer various pricing models to suit your specific needs and budget. Job Description: OptraSCAN is seeking a highly detail-oriented and knowle...

Company Overview: Optra Scan Pvt Ltd is a leading provider of digital pathology solutions, revolutionizing the way pathology practices worldwide, managing and interpreting diagnostic information. Our cutting-edge technology empowers pathologists to improve efficiency, accuracy, and patient care through digitalization and artificial intelligence. Job Description: OptraSCAN is seeking a highly detail-oriented and knowledgeable Technical Writer - Regulatory to create, manage, and maintain regulatory documentation required for product approvals, certifications, and market access in global markets. This role involves a combination of regulatory strategy and high-quality technical writing for medi...

ZEISS in India is headquartered in Bengaluru and present in the fields of Industrial Quality Solutions, Research Microscopy Solutions, Medical Technology, Vision Care and Sports & Cine Optics. ZEISS India has 3 production facilities, R&D center, Global IT services and about 40 Sales & Service offices in almost all Tier I and Tier II cities in India. With 2200+ employees and continued investments over 25 years in India, ZEISS success story in India is continuing at a rapid pace. Purpose of this position/Position summary Implement, maintain and further develop the ZEISS India Management System, aligned with the Corporate ZEISS Management System, maintain the ISO 9001 certification requirements...

Job Description The Software Quality Engineer is responsible for Software Quality relative to the design and development of company products, software reliability, developing and maintaining processes and procedures, and assuring adherence to the software development lifecycle across Abbott. Responsible for maintaining a strong collaborative partnership with cross-site and cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. About the team: The Software Quality Engineering team provides a fast-paced, dynamic work environment where engineers work closely with cross functional teams to provide software services to p...

Job Description Position: Associate Junior Executive Manufacturing Position Reports to: Manager Manufacturing Downline Reporting: Operators Department: Manufacturing 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,...

What you will do Independently processing results of PFA assessments. Initiate, organize and coordinate global containment actions Ensure that data is documented for the different sites. Together with the PFA specialist create a communication to affected parties. Provide necessary information to regulatory compliance team for reporting. Presenting PFA/commercial hold relevant processes and cases during audits Preparing weekly, monthly and quarterly Commercial Hold relevant statistics Performing training of colleagues and managers by procedural changes What you need Required Skills: B. Tech / M.Tech Mechanical, Biotechnology with hands on experience of working on PFAs, and Commercial Holds. H...

Job Description Summary In this role you will develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. You will ensure that projects and products are capable and will meet specified standards (Preventive). You will have In-depth understanding of key business drivers; uses this understanding to accomplish own work. You will ensure each project is developed & released meeting customer expectations and regulatory requirements . GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and jo...

Job Description Summary In this role you will develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. You will ensure that projects and products are capable and will meet specified standards (Preventive). You will have In-depth understanding of key business drivers; uses this understanding to accomplish own work. You will ensure each project is developed & released meeting customer expectations and regulatory requirements . GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and jo...

Position: Manufacturing Process Engineer Reporting to: Quality Manager Location: Pillaipakkam (Factory) Summary: As a process engineer, you will analyse and optimize manufacturing and industrial processes to improve efficiency and reduce costs. This includes process designing, troubleshooting, process optimization, process analysis, process documentation, quality control, project management, process automation and quality assurance. You will also collaborate with cross-functional teams, implement process improvement initiatives and contribute to the overall success of our organization. Roles responsibilities: 1.Conduct detailed process evaluations and gap analyses to identify areas for impro...

Skills: Ensure QMS compliance with ISO 13485:2016, ZED, and GMP standards. Review and approve batch records, SOPs, and quality documents. Oversee product packaging, labeling, testing, and release for dispatch. Investigate and manage deviations, complaints, CAPAs, and change controls. Monitor warehouse conditions, equipment calibrations, and validation records. Coordinate internal/external audits, inspections, and supplier evaluations. Ensure timely product testing and maintain ETO batch records. Conduct training sessions on quality procedures as per schedule. Prepare Certificates of Analysis and assist in regulatory certifications. Coordinate with cross-functional teams for QMS adherence and...

A Day in the Life Collaborating with cross-functional teams to develop comprehensive product risk management files, including the risk management plan, Hazard Analysis, DFMEA, and risk management report, adhering to ISO 14971 standards. Responsible for maintaining highest standards of product reliability and patient well-being through gather and analyze data, write reports, and communicate with regulatory agencies on ensuring product safety. Responsibilities may include the following and other duties may be assigned: Capability to conduct thorough reviews of new and modified product design documentation, assessing quality characteristics such as manufacturability, serviceability, testability...

A Day in the Life A Day in the Life The Software Test Engineer will focus on supporting medical device software testing. The position is a hands-on test development & individual contributor role with a dynamic set of responsibilities in a complex software system including test design & development, design of test automation framework, test scripts development and test execution. Responsibilities may include the following and other duties may be assigned Test execution and document software using manual and/or automation methodologies. Thoughtfully develop testing strategies and protocols with state-of-the-art software best practices. Develop test strategies, review test designs, and validate...

Career Category Quality Job Description Let s do this. Let s change the world. In this vital role you will act as the Quality Engineering representative on multi-functional teams, employ quality principles and company s procedures including but not limited to the areas of device design control, Change Control and NC/CAPA, Risk Management, Human Factors Engineering, to ensure development and lifecycle management of final product align with dynamic global regulations and standards. The Sr Quality Engineer will be an integral part of the design and development of combination products, providing quality oversight of the processes and deliverables generated throughout development and commercializ...

Manage Change Notices in Windchill PLM, handle QMS docs and CAD files, process ECNs/ECRs, ensure ISO 13485 compliance, support QMS improvements, and collaborate globally for timely and accurate documentation Required Candidate profile This is for quality management document control.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Gurgaon, Haryana, India Job Description: Required Qualification...