9 Iso13485 Jobs

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., MDR-2017). Maintain proper documentation (MFRs, SOPs, Batch Records). Participate in internal and external audits; support CAR (Corrections and Corrective Actions). To do the Risk Management of Production related processes. 3. Team Leadership & Training Supervise production team, including line operators and shift supervisors. Conduct training programs on hygiene, process controls, and SOPs. Monitor team performance, attendance, and shift efficiency. 4. Equipment & Facility Management Oversee maintenance and calibration of machines and equipments. Ensure readiness of controlled environments. Support validation activities (IQ, OQ, PQ) for equipment and processes. 5. Inventory & Material Handling Monitor raw material consumption and work-in-progress (WIP) inventory. Ensure traceability and control of critical components and lot numbers. Coordinate with stores for timely availability of materials. 6. Process Improvement & Lean Manufacturing Identify and implement process improvements for efficiency, waste reduction, and cost savings. Use lean tools like 5S and root cause analysis. 7. Documentation & Reporting Maintain accurate production records, reports, and logs and ensure good documentation practices are followed. Track KPIs such as OEE, yield, rejection rate, and downtime. Report production issues, deviations, and incidents to management. 8. Safety & Hygiene Ensure compliance with EHS (Environment, Health & Safety) policies. Implement workplace safety measures and incident response procedures. Conduct regular audits and hygiene checks. 9. Regulatory & Audit Readiness Keep the production area audit-ready for regulatory inspections (Notified Body, CDSCO). Support documentation review, observations response, and implementation of audit findings. 10. Any other task assigned by reporting Manager. The Job responsibilities may be revised as per company requirements as and when required.

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 Customer Complaints Handling Corrective Action & Preventive Action (CAPA). Suggest & implement new document/ process/ system. Preferred candidate profile Should be a Graduate of Biological Science. (Bsc & Btech Biotechnology) Minimum 1 to 2 years of relevant experience required Certified internal auditor for ISO 13485;2016. Experience working with 3D printers in the healthcare segment. Strong organisational skills that reflect the ability to perform and prioritise multiple tasks seamlessly with excellent attention to detail.

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 applicable. A distinguished champion on patient safety and quality with expertise on quality and compliance principles like IEC60601, IEC 62304, IEC62366, 21CFR806. You will be acting as subject matter expert to provide guidance on product design quality, safety, reliability, serviceability, maintainability, manufacturability and other aspect in collaboration with business and technical SMEs. Well conversant with QMS requirements in accordance with ISO13485:2016 and ISO14971. Expert in medical device risk management principles including risk evaluation, assessment, risk determination, mitigation and risk benefit analysis. You will be acting as facilitator for risk management activities in accordance with ISO14971 and other applicable regulatory requirements. You're the right fit if: (4 x bullets max) Experience: 12 to 20 Years, minimum 10 years in Medical device industry. Bachelor's in engineering or quality management, with 12 to 20 Years, minimum 10 years in Medical device industry. Proven knowledge of the FDA regulations for Design Controls for medical devices is a must and the combination with (extensive) experience with regulatory inspections has a very strong preference. Product Quality Engineering and Design Control experience is a requirement. Certification in Software Quality Engineering (CSQE) from ASQ or other bodies is desirable In-depth knowledge and a proven track record in implementing and applying concepts in the fields of designing in quality, reliability and problem-solving techniques have a strong preference. Leadership experience and good change management and influencing skills (required) You are Customer, Patient Safety and Quality focused. Understanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR. Advanced level knowledge of IEC62304, IEC62366 and ISO14971 has a strong preference. Excellent communication skills, able to clearly and concisely summarize complex technical problems You combine analytical and conceptual thinking, physical insight, system view, flexibility and a Handson mentality to deliver sustainable results and creative solutions. You are a motivated self-propelling person, with determination to succeed and the ability to manage change. Excellent organizational skills to lead and track deliverables Strong influencing skills power of persuasion, perseverance, getting things done mentality. 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 companyu2019s facilities. Field roles are most effectively done outside of the companyu2019s main facilities, generally at the customersu2019 or suppliersu2019 locations. Indicate if this role is an office/field/onsite role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. u2022 Learn more about . u2022 Discover . u2022 Learn more about . If youu2019re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion .

#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 maintain product marketability in India. Key Accountabilities:- Provide Regulatory Support for timely new product launches. Well versed with filing application of Import Registration/Import license/Test License on SUGAM portal and NSWS & BIS Regulations & Certification. Stay abreast of regulatory procedures and changes in regulatory climate. Responsible for managing BIS application and submission procedures To review Medical Device dossier and technical documents to support country specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents and take appropriate actions to obtain regulatory approvals as planned. Address queries from CDSCO/NSWS on submitted applications, provide regulatory support and assist in preparing a response to regulatory authoritys questions within assigned timelines. Responsible for managing modifications to a device after it has received regulatory approval. Work with other departments and communicate the submission requirements when documents are needed for regulatory submission. Timely tracking and reconciliation of routine submissions/activities/Query response Post-Market Surveillance: Manage post-market surveillance activities, including adverse event reporting, field safety corrective actions, and vigilance reporting. Minimum Knowledge & Experience required for the position: Bachelor's/ Masters degree in a relevant field, such as life sciences, or regulatory affairs. Around 5+ years of relevant experience in Healthcare Industry (Medical Devices/IVDs) in Regulatory Affairs (MNCs) is desirable. Skills & Capabilities: Hands-on experience with the NSWS/ SUGAM portal and CDSCO online submission process. Strong understanding of Indian regulatory frameworks including CDSCO & BIS. Attention to detail and critical thinking skills Ability to work collaboratively with cross-functional teams. Note:- Looking Male candidate with decent exposure into RA role with reputed MNC's. If above role matches with your experience & aspirations than share CV to: recruit.corp12@apexservices.in

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 and Purchasing Spec. Interface between manufacturer and supplier for resolving doubts and issues. Coordinate with SQE to get necessary documents from supplier to complete APQP (IRF, IND, PSW, RSL). Knowledge In Label ad IFUs gap assessment activities. Manage PCN received from manufacturer to implementation. Manage & Document Supplier initiated change request. Create and update supplier data base in PLM. Ensure suppliers meet Drawing and Regulatory requirements. Being in a part of CFT team for supplier nonconforming material investigations. To succeed in this role, you should have the following skills and experience: Completed engineering studies at university level; BE/BTech in Mechanical, Electrical, Electronics, Biomedical Engineering or equivalent stream. 2-3 years of work experience in medical device manufacturing & supplier quality related background. Knowledge in ISO 13485, ISO 15223 & ISO 14971. Expert in GDP procedures. Experience in supplier communication, Engineering Change. Knowledge of Global Medical Quality and Regulatory Standards e.g. IEC, FDA, UL, CE etc. will be an added advantage. Disciplined team worker, ability to work independently. Ability to present and articulate ideas to key stakeholders and leadership team. Excellent communication skills. Quality mindset in design and documentation.

Bachelors degree in mechanical engineering Min 5 years of experience working as a mechanical design engineer New product development per ISO13485design control processes Experience in solid modelling and print creation with Creo

Role & responsibilities Knowledge on Design, develop, and improve manufacturing processes for medical devices. Support and implement lean manufacturing and Six Sigma methodologies to enhance efficiency and reduce waste. Ensure manufacturing processes comply with FDA (21 CFR 820), ISO 13485, and other relevant medical device regulations Develop and maintain process validation (IQ, OQ, PQ) and documentation. Support root cause analysis (RCA) and corrective/preventive actions (CAPA) Provide technical support for new product introductions (NPI) and process transfers Knowledge on lean tools and techniques EXPERTISE AND QUALIFICATION S VSM, process improvement, layout design

Job Description Overview / Purpose of the Job Inspection of Mechanical Parts Tasks Summary & Responsibilities Dimensional Inspection / Material verification as per drawing Visual inspection against customer guidelines / Standards Documentation , Calibration & NCMR control First Article Verification of New Parts with reference to engineering specification Supplier Visit & Onsite inspection 5S & Safe Keeping Measuring instruments Internal / External communication related to inspection & NCMR Requirements for the position Educational Diploma Mechanical Engineering ( 3 Year Course) Work Experience On Hand Inspection Experience in Mechanical Industry Sheet Metal / Machining / Moulding, Painted & Plated parts On hand experience in Measuring Instruments and gauges, LH 2D, VMS, CMM Special Qualifications, Knowledge & Skills Experience in welding / NDT & Aero Space industry Preferred Other important things to note Knowledge in ISO 9001/ ISO13485/ AS91000, Computer & Softwares

Joining timelines: immediate to 1 month Candidate should have a minimum of 8+ years overall Experience Relevant should be at least 2-3 years with lead exp Should have extensive experience in Test documenation like Test Plan, RTM, Test Strategy, Test Data, Bug Report, Test execution report including Test Case creation, and Defect Handling (severity Vs priority) Hands-on experience in Validation test plan, Validation test strategy Validation test documentation, and guiding Should have strong experience in Manual Testing Experience in Test case execution and Bug fixes. should be ready to work as individual contributor too along with Lead role. Experience in Test management tools (Jira and ALM),Knowledge of DB testing Expertise in performing different types of testing like Functional Testing, System Testing, Regression Testing. good to have :Life science or Clinical Trail Domain Experience Working in an Agile environment. We also offer: o Group Health Insurance covering family of 4 o Term Insurance and Accident Insurance o Paid Holidays & Earned Leaves o Paid Parental LeaveoLearning & Career Development o Employee Wellness