215 Iso 13485 Jobs - Page 6

Job Description Job Title: Risk Management SME Medical Devices Location: Pune Employment Type: Full-Time Experience: 10+ Years Industry: Medical Devices Job Summary: We are seeking a highly experienced Risk Management Subject Matter Expert (SME) with a strong background in medical device regulatory and quality systems. The ideal candidate will have 10+ years of experience working with cross-functional teams including RD, Regulatory Affairs, and Design Quality to ensure product compliance throughout the lifecycle. This role requires deep knowledge of risk management, global regulatory requirements (EU MDR, US FDA 510(k)), and relevant medical device standards. Key Responsibilities: Lead and execute risk management activities throughout the product lifecycle. Review and simplify Risk Management Files (RMF), Risk Mitigation Measures (RMM), BRDs, DHFs, traceability matrices, design requirements, and IFUs. Ensure compliance with global medical device regulations and standards (ISO 14971, ISO 13485, IEC 60601-1, IEC 62366-1, ISO 10993-1, MEDDEV 2.7/4). Collaborate with RD and Quality teams to validate design inputs (Usability, Safety, Reliability, etc.). Oversee and contribute to Verification Validation (VV) activities. Manage quality plans across all stages of the product lifecycle and ensure execution oversight. Conduct technical assessments and post-market analysis on product performance. Provide analytics and statistical reporting for post-market surveillance. Act as the primary quality representative in project teams ensuring design compliance at every milestone. Requirements: Degree in Mechanical/Electrical Engineering, Applied Sciences, or related field. 10+ years of experience in medical device industry focusing on risk management and regulatory compliance. Expertise in quality management systems (QMS) like ISO 13485, MDSAP, and EU MDR. Hands-on experience with quality and product development systems. Strong communication and cross-functional collaboration skills. Proven ability to drive quality excellence and compliance. Job Overview Posted date : 27 Jun 2025 Location : Any Location, India Experience : 10+ years

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don t settle for the mediocre. Each of us is driven to help improve patients lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. Post-market surveillance involves collecting, analyzing, and interpreting data related to medical device use in real-world clinical settings. The Post Market Surveillance Associate will be responsible for drafting, analyzing and issuance of Periodic Safety Update Reports in accordance with EU and other country Regulations. Essential Duties and Responsibilities: Drafting and issuance of Post Market Surveillance Plans as per the requirement. Collect and analyze the required data and Draft the Periodic Safety Update Reports and Post Market Surveillance Reports. Evaluate the emerging risks from the data analyzed. Working with the stakeholders to address the issues, roadblocks keeping the process smooth. Timely issuance of PMS Documents. To work with the team to streamline the PMS process. Also support the complaint process by owing and processing quality complaint as per applicable procedures. Author and submit applicable regulatory reports (MDR, MIR, etc) to competent authorities when deemed required. Performs other duties as needed and assigned. Qualifications: Excellent verbal and written communication skills. Analytical approach to problem solving. Ability to handle and manage workload independently. Education and/or Experience: bachelors Degree - Preferred: engineering, nursing, biomedical, life science, or equivalent (S.T.E.M.). Prior experience (2+ years) with PMS requirements (PMSP, PSUR) in medical device industry. Experience with current U.S. FDA, EUMDR, MDD, ISO 13485, ISO9001, MDSAP and/or CMDR regulations, standards, and guidance documents (Preferred). Reasonable Accommodation

Role & responsibilities Degree in Marketing, Sciences, Biomedical Engineering, or related discipline. Medical Device Certification Business experience preferred. About 8 years of experience with a Medical Devices manufacturer and / or Notified Body including about 2 years in Sales desirable. Good Communicator & writing skills. Social Media selling exposure. Well-read and updated on the Medical Device Sector happenings. Experience with ISO 13485, MDSAP, MDD, MDR, IVDR certifications. Establish rapport and liaison with Regulatory bodies and seek advance information on legal/regulatory introduction/amendments. Connects and actively interacts with Medical Device Industry forums. Generates proposals in compliance with Notified /Accreditation Body requirements and/or product sector requirements. Maintains accurate records of all sales and prospecting activities including sales calls, presentations, closed sales, and follow-up. Adheres to internal standards, policies and procedures.

Role & responsibilities Degree in Marketing, Sciences, Biomedical Engineering, or related discipline. Medical Device Certification Business experience preferred. About 8 years of experience with a Medical Devices manufacturer and / or Notified Body including about 2 years in Sales desirable. Social Media selling exposure. Well-read and updated on the Medical Device Sector happenings. Experience with ISO 13485, MDSAP, MDD, MDR, IVDR certifications. Mandatory skills: Minimum 5 years of experience handling Medical Devices sales, Certification body experience, team management exposure.

Role & responsibilities Degree in Marketing, Sciences, Biomedical Engineering, or related discipline. Medical Device Certification Business experience preferred. About 8 years of experience with a Medical Devices manufacturer and / or Notified Body including about 2 years in Sales desirable. Social Media selling exposure. Well-read and updated on the Medical Device Sector happenings. Experience with ISO 13485, MDSAP, MDD, MDR, IVDR certifications. Mandatory skills: Minimum 5 years of experience handling Medical Devices sales, Certification body experience, team management exposure.

Coaching delivery teams on the quality management system, tailoring to create project specific processes, quality goals and plans to achieve project objectives Reviewing delivery artefacts for compliance and conducting delivery reviews Help in planning and conducting internal audits including support departments Handling customer complaints and ensuring completion of customer satisfaction surveys Facilitate continual improvement and break through process improvements Support in data analysis and use of statistics in creating baselines and accessing stability of processes Support in management reviews and reporting Ensure compliance to ISO 9001, ISO 13485 and CMMI L5 Should have at least 2 years experience in software development and testing activities and minimum of 3 years in software quality assurance activities Should have completed ISO 9001 implementation or lead auditor certification Would be good have CMMI DEV Implementation experience and Certified in Basic statistics such as Six Sigma Green belt. Nice to have the following certificate: CMMI DEV or SVC associate certificate AS9100 / ISO 13485 / Automotive Safety Certificates Basic understanding of AI / ML Experience in process definition and high maturity practices Participation in CMMI appraisals

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 metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms. Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy. A job at this level is likely to be an individual contributor, with proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations. Impacts projects, processes and procedures in own field. The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of guidance. Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions. Required Qualifications For roles outside of the USA- This role requires advanced experience in the Quality & Healthcare Quality. Knowledge level is comparable to a Bachelors degree from an accredited university or college ( or a high school diploma with relevant experience). For roles in USA - Bachelors degree from an accredited university or college (or a high school diploma / GED with at least 6 years of experience in Job Family Group(s)/Function(s)). Desired Characteristics Experience in Quality Management System Manufacturing QMS Exposure Experience with ISO 13485 Experience with FDA CAPA, process improvement Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills. Inclusion and Diversity GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. . Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you d expect from an organization with global strength and scale, and you ll be surrounded by career opportunities in a culture that fosters care, collaboration and support Disclaimer: GE HealthCare will never ask for payment to process documents, refer you to a third party to process applications or visas, or ask you to pay costs. Never send money to anyone suggesting they can provide employment with GE HealthCare. If you suspect you have received a fraudulent call , please fill out the form below: https: / / www.ge.com / careers / fraud Relocation Assistance Provided: No

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 regulatory compliance. Guide assay optimization, troubleshooting, and validation, with a focus on enhancing sensitivity, specificity, and reproducibility of quantitative LFA platforms. Allocate resources efficiently, manage budgets, and ensure procurement of critical raw materials and reagents for assay development. Provide regular project updates to senior management and stakeholders; prepare technical reports and presentations as needed. Drive process improvements and implement best practices for assay development, scale-up, and transfer to manufacturing. Identify project risks and develop contingency plans to ensure on-time delivery and high-quality outcomes. Candidate Qualifications Education: PhD or Master s degree in Biochemistry, Biotechnology, Analytical Chemistry, or a related field. Experience: Minimum 8+ years of hands-on experience in lateral flow assay development, with a proven track record of delivering quantitative colloidal gold-based products to the commercial market. Experience with fluorescence-based assays is a plus. Regulatory & Quality Understanding: Familiarity with IVD regulatory requirements (CDSCO and CE-IVD), quality management systems (e.g., ISO 13485), and design transfer to manufacturing. Communication: Excellent verbal and written communication skills; ability to convey complex technical concepts to diverse audiences. Problem-Solving: Strong analytical and troubleshooting skills, with the ability to resolve technical and operational challenges quickly and effectively. Commercial Acumen: Experience working with cross-functional teams to bring diagnostic products from R&D through to successful market launch.

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 workflows. For more than four decades we ve been advancing what s possible at the point of care. HemoCue offers point-of-care testing for hemoglobin, glucose and HbA1c as well as total and differential white blood cell count. The Development Engineer, Firmware at HemoCue is responsible for documentation and test of design changes within the Sustaining Engineering department, mainly firmware changes. This position is part of the R&D-team located in Bangalore and will be on-site. At HemoCue, our vision is to do things easier, to do things better, and to do them right. You will be a part of the Sustaining Engineering and report to the Director of Sustaining Engineering, (located in at headquarter in Sweden). You will be responsible for planning, design, implementation, documentation, and test of software modules. If you thrive in a fast-paced environment, enjoy working independently but also cross-functionally and want to work to build a world-class R&D organization read on. In this role, you will have the opportunity to: Perform product support activities for current products, primary instrument activities Cross-functional work with operations department and/or subcontractor by solving problems, coordinating, verifying and approving changes to HemoCue products Execute and/or participate in product lifecycle activities, such as CAPAs, engineering change orders, cost down activities and general sustaining engineering activities The essential requirements of the job include: University degree: Master of Science, Bachelor of Science or Engineering or equivalent work experience within Software and at least 3 years of work experience Knowledge of software development tools, design patterns and programming paradigms. Experience of C and C++ development on embedded systems (ARM microcontrollers). Knowledge of analog and digital electronics Your main communication language will be English Knowledge about ISO 13485, QSReg and Design Control It would be a plus if you also possess previous experience in: Experience from product development of medical devices Experience from design changes for medical devices Cybersecurity Join a winning team today. Together, we ll accelerate the real-life impact of tomorrow s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . Join our winning team today. Together, we ll accelerate the real-life impact of tomorrow s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

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 support Corrective and Preventive Actions (CAPAs), from initiation and investigation to implementation and verification of effectiveness. Audits: Facilitate and support internal and external audits (e.g., regulatory inspections, notified body audits), ensuring readiness and effective follow-up on findings. Supplier Quality: Oversee supplier qualification, monitoring, and quality agreements to ensure high standards across our supply chain. Training & Calibration: Manage and track quality-related training programs and ensure timely calibration of essential equipment. Cross-functional Collaboration: Partner with teams like Product Development to integrate quality requirements early in the design process and support overall quality improvements. Regulatory Submissions: Provide critical support for regulatory submissions, ensuring all necessary quality documentation is complete and accurate.

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. Youll ensure full compliance with standards like IEC 60601, ISO 13485/14971, IEC 62366, and FDA 21 CFR 820. • Key Responsibilities End-to-End Electronics Design Drive schematic design and PCB layout from scratch using Altium Designer , including creation of symbols, footprints, library management, and templates. Perform detailed multi-layer board design with emphasis on signal integrity, EMI/EMC, thermal performance, DRC/ERC, and DFM/DFT. Components & Libraries Build and maintain Altium library assets (schematics, PCB footprints, 3D models), and manage lifecycle with traceability for compliance. Medical-Grade Standards & Design Control Design compliant with IEC 60601 (11 & 12), ISO 13485, ISO 14971, IEC 62366, and FDA 21 CFR 820 processes. Support DFMEA/risk management and maintain complete Design History File (DHF). Prototype & Test Develop and execute test setups for verification/validation, including electrical safety, EMC, and performance benchmarks. Debug via oscilloscopes, spectrum analyzers, and logic analyzers through first builds and pilot runs. Cross-Functional Collaboration Align with firmware, mechanical, QA, procurement, and manufacturing teams to ensure seamless integration and production readiness. Assist in NPI, including PCB prototype coordination, pilot transfers, and documentation handoff. Documentation & Leadership Prepare engineering documents: design specs, BOMs, assembly/test procedures, test plans, and validation reports. Lead schematic/PCB design reviews and mentor junior engineers. Required Skills & Experience Bachelors or Masters in Electronics/Electrical/Biomedical Engineering. 57 years in electronics design, ideally in medical-device or similarly regulated sectors. Proficiency in Altium Designer (schematic capture, multi-layer PCB layout, library and template creation). Solid knowledge of analog/digital circuit design, power distribution, sensor/MCU interfaces, high-speed considerations. Hands-on testing experience with oscilloscopes, logic analyzers, EMC analyzers. Understanding of medical standards: IEC 60601 series, ISO 13485/14971, IEC 62366, FDA 21 CFR 820. Excellent documentation skills, attention to detail, and teamwork orientation. Desired (Plus) Skills Experience in signal integrity, EMC/EMI mitigation, or high-speed board designs. Familiarity with embedded firmware collaboration or sensor-driven system design. DFMEA, obsolescence planning, and life-cycle management proficiency. Knowledge of RoHS, IPC standards, and medical usability engineering. Benefits Competitive compensation, performance bonuses Medical insurance and wellness initiatives Career growth, training, and certification support Collaborative global environment shaping medical-grade technology How to Apply Send your CV and cover letter detailing Altium-based schematic & PCB design experience in medical devices to career@innoiq.com with subject: Electronics Engineer Medical Device, Pune (Altium)

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 a passionate and detail-oriented Embedded Software Engineer to join our growing engineering team. You will play a critical role in the development of embedded software solutions for cutting-edge medical devices , ensuring compliance with regulatory standards and delivering high-quality products that positively impact patient care. Key Responsibilities: Design, develop, test, and maintain embedded software for medical devices Collaborate with cross-functional teams including electronics, mechanical, and system engineers Write efficient, reliable, and reusable code in C/C++ for embedded platforms Contribute to software architecture and system integration for real-time embedded systems Conduct software verification, validation, and unit testing in accordance with IEC 62304 Support design documentation and risk management activities per ISO 13485 and ISO 14971 Debug hardware/software integration issues using appropriate tools and methods Participate in design reviews, code reviews, and continuous improvement activities Required Qualifications: Bachelors or Masters degree in Electronics Engineering , Computer Engineering , Embedded Systems , or related field 2+ years of experience in embedded software development , preferably in the medical device domain Proficiency in C/C++ programming and real-time embedded systems Experience with microcontrollers , RTOS , and hardware-software interfacing Strong understanding of software development life cycle in regulated environments Knowledge of medical standards such as IEC 62304 , ISO 13485 , and ISO 14971 Good problem-solving skills and attention to detail Proficient in written and spoken English Preferred Qualifications: Experience with wireless communication protocols BLE, NFC Familiarity with version control systems Git and tools like Jira, Confluence Experience in developing software under Agile or V-model process Why Join Us? Be part of a global team developing life-enhancing medical technologies Work in a culture that values innovation , precision , and continuous learning Opportunities to grow in a fast-paced , quality-driven , and regulatory-compliant environment Exposure to international projects and collaboration with leading medical device companies

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 for internal / external audit compliance for ISO and CE marking Responsible for surveillance of regulatory guidance/ standards applicable to medical devices in the respective geographies in which Cipla products are distributed. Key Accountabilities: Develop, establish and maintain the QMS for medical devices according to EU MDR and ISO 13485 requirements. Surveillance of new/updated regulatory guidance/ ISO standards applicable to medical devices as per Ciplas product portfolio to ensure compliance to latest regulations. Surveillance of EU noncompliance reports / CDSCO / USFDA etc that are applicable to medical devices manufactured by Cipla to enable continuous improvement. Execution of Quality Management Review meeting for Medical devices and implementation of actions derived in the QMR meetings. Conduct audit of Vendors / contract manufacturers/ outsourced activities associated with medical device manufacturing/ servicing/ testing/ distribution. Ensure timely submission of quality documents to fulfil regulatory requirements. Major Activities / Tasks: Develop and establish Management responsibility system as per ISO 13485 and EU MDR Develop and establish design control system for EU market. Develop and establish key performance indicators (KPIs) for monitoring site performance and effectiveness of QMS as per ISO 13485. Prepare SOPs, Quality manual etc.as per ISO 13485/ EU MDR. Responsible to maintain compliance to ISO 13485 by adhering to SOPs and ensuring control and oversight over adherence by respective depts to SOPs. Periodic review of SOPs related to medical devices as per regulatory requirements and update. Arrange training and promote awareness among cross functional teams on ISO 13485 QMS and CE Marking Ensure readiness from QMS standpoint for internal and external audits. Provide guidance and support during internal and external audits examining compliance to EU MDR/ISO 13485 requirements. Co-ordinate with cross functional teams for internal/ external audit compliance. Create library of ISO standards. Review new/upcoming/ draft/ revised/ final regulatory guidance/ ISO standards related to medical devices applicable as per Ciplas product portfolio. Gap assessment of the guidance / standards in comparison to QMS at Cipla and identify suitable actions prior to implementation of the guidance/standard. Monitor implementation of the actions to enable continuous improvement. Schedule quality management review (QMR) meeting for medical devices. Collate data required for the QMR and prepare the presentation on site performance to monitor effectiveness of Quality management system. Appraise management representative regarding critical issues. Monitor implementation of the action plans derived from QMR by coordinating with other cross functional team. Audit of Vendors supplying Medical devices and Invitro diagnostic kits, completing audit documentation and verifying actions taken by the audited site to correct non-conformances observed. Audit of CMOs manufacturing medical devices, completing audit documentation, and verifying actions taken by the audited site to correct non-conformances observed. Audit of outsourced activities related to medical devices manufacturing/ servicing/ testing/ distribution. Coordinate with RA, QA team and Pharmaco vigilance team through emails and phone to enable timely submission of the documents. Major Challenges: Establishing Quality Management System for Medical devices according to EU MDR / ISO 13485 is new for Cipla, hence developing and maintaining it will be a challenge. Cross functional support is key in ensuring adherence to QMS, as challenge is awareness about EU/ ISO 13485 certification requirements is low in cross functional teams such as IPD/ RA/ SCM/FPS/ DSD, Marketing. Same can be overcome by promoting awareness about EU MDR/ISO 13485 requirements at the outset/ from time to time. Engage in Notified bodies audits for ISO and CE marking audits and coordinate with all Cipla teams for audit management. Coordinate with Cipla team for audit compliance. Skills & Knowledge: Educational qualifications: MSc./ MPharm/ if MTech then in Biomedical engineering; Certificate courses/diploma in ISO audits highly welcome Relevant experience: At least 9-10 years of experience in Quality of Medical Devices/IVDs /Implants Experience in regulated market product approvals e.g. US FDA is a high plus

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 perform the validation activity. To analyze the process data as per ISO 13485. To ensure that test methods are strictly adhered to, test reports are forwarded to the designated authority.

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 Affairs Executive with 3-4 years of experience in medical device regulation and compliance. Proficient in preparing and submitting regulatory filings for product approvals, conducting clinical evaluations, managing risk assessments, and ensuring post-market compliance across multiple regions. Experienced in EU MDR 2017/745, US FDA regulations, Indian MDR 2017, and ISO 13485 standards. Proven ability to collaborate with cross-functional teams to meet regulatory requirements and deliver high-quality documentation, including Clinical Evaluation Reports (CER), Post Market Surveillance (PMS) reports, and PMCF studies. Company Profile: One of the Leading manufacturers and suppliers of Orthopedic Implants and instruments, founded in 1987 and having manufacturing unit at Rai Industrial Area, District Sonipat, Haryana and Corporate Office in Phool Bagh, Rampura, New Delhi Near Ashok Park Main Metro Station.

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 knowledge of labeling regulations. Minimizes down time by reducing production rework and recalls. Job Description Varex Imaging , headquartered in Salt Lake City, USA, is a leading innovator, developer, and manufacturer of X-ray imaging component solutions, which includes X-ray tubes, digital flat panel detectors, software, and other key components of X-ray imaging systems. Your Role... 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 knowledge of labelling regulations. Minimizes down time by reducing production rework and recalls. Your Profile... Bachelor s degree in mechanical engineering Possess in-depth knowledge about the IQC Equipment s, CMM, Calipers, Height Gauge, Image Dimension Measurements etc. Expertise in CMM(Mitutoyo) Interpret and apply GD&T (Geometric Dimensioning and Tolerancing) to validate parts. Ability to read Engineering drawings and create inspection Plans and Programs. Conduct hands-on inspection of machined parts, ensuring high accuracy measurements and adherence to quality standards. Incoming Quality Checks Background ISO-13485 desired Experience with SAP software desired. 5+years of related experience What we offer A unique opportunity to become part of growing organization in India being part of a global market leader in Xray imaging components. Excellent development potential. An international work environment with global teams collaborating on various projects across several countries. Competitive compensation package including participation in Varex incentive plans. Corporate Health Benefits. Additional benefits will be added as we grow. Time Type: Full time Job Type: Regular Work Shift: N/A Pay Rate Type: Salary

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. Provide regulatory guidance and support to internal teams and stakeholders, including communicating regulatory changes, conducting training on quality and regulatory requirements, and fostering a culture of compliance within the organization. Experience interacting with the FDA and other regulatory authorities. Excellent analytical skills and the ability to synthesize trending data into meaningful information for the organization.

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 procedures and subsequent reporting. Issuance and handling of change control, non conformity, CAPA in IMSxpress Issuance and handling of Deviations Issuance and maintenance of BMR Handling, Recording and compilation of customer complaints Updation and maintenance of departmental risk register. Participating in product Validation. Review of packing order, checking of labels and Shipments to customers. Participating in Internal/external audit as per audit agenda and responsibility allotted. Preferred candidate profile Should have a Bachelors or Master's degree in pharmacy/biotechnology/Biochemistry or other relevant scientific discipline with 2/3 years experience in Quality Assurance. Knowledge of GMP standards, SOPs and quality management systems • Awareness of QMS as per ISO13485: 2016 and ISO 9001:2015 standards • Data collection and management • Customer service orientation • Excellent relationship management skills with the ability to engage, negotiate and manage key stakeholders and suppliers • Strong and confident negotiator with the ability to negotiate at all levels • Excellent communication, interpersonal and influencing skills • Results orientated with ability to plan and deliver against deadlines • Ability to add value, reduce costs and make improvements • Computer literate, especially Excel skills

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 responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms. Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy. A job at this level is likely to be an individual contributor, with proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations. Impacts projects, processes and procedures in own field. The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of guidance. Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions. Required Qualifications This role requires advanced experience in the Quality & Healthcare Quality. Knowledge level is comparable to a Bachelors degree from an accredited university or college ( or a high school diploma with relevant experience). Minimum 5 years in Healthcare Quality and Regulatory Desired Characteristics Good Knowledge on Medical Device Standards and Regulations Qualified internal auditor (ISO 9001, ISO 13485) Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills. Inclusion and Diversity GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. . Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you d expect from an organization with global strength and scale, and you ll be surrounded by career opportunities in a culture that fosters care, collaboration and support Disclaimer: GE HealthCare will never ask for payment to process documents, refer you to a third party to process applications or visas, or ask you to pay costs. Never send money to anyone suggesting they can provide employment with GE HealthCare. If you suspect you have received a fraudulent call , please fill out the form below: https: / / www.ge.com / careers / fraud Relocation Assistance Provided: No

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 clear direction and operating mechanisms for ensuring effective monitoring and reporting of performance and safety of commercialized products, ensuring ongoing compliance with regulatory standards. Support day to day activities for multiple work-stream teams through managing project plans, resourcing, status reporting, resolving issues, identifying project risks and accountability for deliverables across multiple entities. Establishes and monitors meaningful metrics for success. Responsible for project performance, risk management, administration, financial management, budgeting, capital planning, forecasting and issue resolution. Manage communication strategies with MEIC and applicable CST entity stakeholder(s) for appropriate mapping of training needs, knowledge transfers and prioritization of work for sustainable long term growth. Support continuous improvement efforts and drive associated change implementation strategies for the product or process being supported. Required Knowledge and Experience Familiarity with FDA Quality System Regulations, EU MDR, ISO 13485, ISO 14971, IEC 60601, and other relevant standards for ensuring compliance to regulatory requirements. Ability to collaborate across the matrix - update crossfunctional (and leadership) teams on project status or issues to the organization and providing training on relevant procedures and policies. Participating in audits (where applicable) and demonstrating the ability to effectively contribute as a team player in various roles, including contributor, subject matter expert, leader, and facilitator. Previous experience working in a cross-functional team environment. Develop templates and lead trainings based on quality system regulations, applicable standards and guidance. Working knowledge and experience with ISO 9001, ISO 13485, ISO 14971, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards. Good verbal and written communication skills Ability to influence others across the organization and/ or locations Hands-on experience with Quality Management Systems (Post market surveillance and reporting, complaint analysis, product acceptance and Design/ Change Control) Strong written, verbal and project management skills

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 following PDLM-MLD process, and support Philips businesses like MRI, RF, IGT, SR&C DXR by ensuring all processes can consistently deliver outputs as per defined specifications and higher-level requirements. Your role: This role is pivotal in collaborating with team members and stakeholders such as Product Development, Inspection, and Design (I&D), Process Design Lifecycle Management (PDLM), and Philips factories and suppliers, to ensure accountability for process and manufacturing requirements aligned with product specifications and test requirements. It involves orchestrating lean manufacturing design in accordance with PDLM workflows, managing PDLM-driven design changes and their implementation, overseeing the process and equipment capability to meet these requirements, and ensuring the accuracy of Manufacturing Bill of Materials (MF BOM) and routing master data until release to shipment, as well as establishing inspection and test criteria for Philips-owned components and assemblies. This role involves guiding and performing process validation-related tests such as TMV, IQ, OQ, and PQ on the shop floor, creating Quality Control Plans and Work Instructions, overseeing equipment installation and supporting process ramp-up at the site, providing factory-side input for SR milestone sign-off and project closure, implementing LCM design changes, and identifying and executing improvements in manufacturing processes, tools, and equipment to enhance quality and efficiency. This role offers professional and personal development opportunities by enabling you to apply lean manufacturing principles, optimize capital expenditure for repeat investments, and gain hands-on experience with obtaining and installing equipment at the site. Youll actively initiate production escalations, solve problems related to manufacturing processes, tools, and equipment, maintain the integrity of master data, identify and execute quality and efficiency improvements, and support the integration of new technologies in factories, fostering a dynamic environment for continual learning and innovation. A high-impact, global organization within Philips that works across all modalities - The Supplier Transfer Excellence Team (STET). STET has been established as an entrepreneurial organization that focuses on fast-paced, high-quality portfolio transfers within the Philips global supply base to mitigate risk & maximize profitability. We work directly with our cross-functional and cross-discipline partners, including marketing, clinical specialists, service personnel and R&D, to deliver solutions through the execution of PDLM, Lifecycle, and Solutions Processes, with deliveries that exceed our customers expectations. Youre the right fit if: (4 x bullets max) 1. Experience. 8-10 years experience. 2. Skills. Design for 6 sigma/DMAIC is preferred. Design for manufacturing, assembly, and testability. Knowledge of special processes like brazing, soldering, and cleaning is advantageous. Basic understanding of ISO 13485 and ISO 14971 is also beneficial. Supportive in CAPA analysis. Capable of working independently in software tools Windchill, Minitab & SAP. Hands-on experience on performing Process Validations, Test Method Validations and MSA Studies (Process capability studies). 3. Education. Bachelor s or master s degree in production, mechanical, Electrical, Electronics engineering 4. Anything else. In return, we offer you a rewarding career at Philips with an attractive package that includes an extensive set of tools to advance your career, such as a personal development budget, training, and coaching, along with an attractive collective health insurance package and the opportunity to purchase Philips shares and products at a discount. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company s facilities. Field roles are most effectively done outside of the company s main facilities, generally at the customers or suppliers locations.

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. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms. Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy. A job at this level is likely to be an individual contributor, with proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations. Impacts projects, processes and procedures in own field. The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of guidance. Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions. Required Qualifications - This role requires advanced experience in the Quality & Healthcare Quality. Knowledge level is comparable to a Bachelors degree from an accredited university or college ( or a high school diploma with relevant experience). Knowledge of ISO 13485 standards and medical device regulations Desired Characteristics Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document and execute programs. Established project management skills. Relocation Assistance Provided: No

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