30 Ce Marking Jobs

As a Sr. Compliance Engineer at SPX FLOW in Pune, you will play a crucial role in ensuring adherence to compliance and product safety standards for products designed for potentially explosive atmospheres. Your expertise in ATEX, EMC, UL, Low Voltage, and Machinery Directive standards will be utilized to lead compliance activities and advocate for best practices throughout the product development lifecycle. Key Responsibilities: - Lead ATEX-related compliance activities and partner with design, product support, and notified bodies to ensure compliance with EMC/EMI standards, UL, LV, CE, and EU Machinery Directive. - Manage the certification process, including submitting samples, technical lia...

Job Title Norm Compliance Officer Job Description Norm Compliance Officer The purpose of this position is to handle end-to-end Norm Compliance activities for Diagnostic X-ray systems as part of the Research and Development team, with all relevant mandatory international and national regulations. Your role: Defining all applicable global product safety certification, product safety, EMC and environmental (if applicable) standards like IEC, EN, and ISO standards required to comply with all applicable international regulations. Define and review product requirements related to guidance, codes and standards to assure norm compliance and decomposition of standard requirements to the individual sy...

Company Description M FAB Orthotics is an R&D first manufacturer of orthotics with one aim: to help people move better. Founded by M FAB, a company with over 20 years of expertise in the fabric industry, M FAB Orthotics applies this heritage of material innovation and manufacturing excellence to create advanced mobility and wellness solutions. Controlling every step from material sourcing through design and production, M FAB Orthotics delivers high-quality, customized orthotic supports that prioritize comfort, durability, and performance. As the Quality Control (QC) Head at our Vapi unit you will be instrumental in ensuring every orthotic product adheres to the highest quality standards. You...

Role Overview: As a Design Review Engineer, your role will involve reviewing product designs and providing feedback to designers to ensure compliance with standards such as UL, CSA, FM, ATEX, IEC, NEC, and others. You will also be responsible for assessing schematic and PCB designs, identifying non-compliance gaps, and working with the design team to address issues. Additionally, you will evaluate drawings, manuals, and reports to ensure they meet the required standards. Key Responsibilities: - Review product designs for compliance with industry standards - Evaluate schematic and PCB designs to ensure they meet IS requirements - Identify non-compliance gaps and collaborate with the design te...

Compliance Engineer --(Bangalore, Karnataka, India) -- Type (Hybrid) Come build something that matters. It takes great people to achieve greatness. People with a sense of purpose and integrity. People with a relentless pursuit of excellence. People who care about making things better For Those Who Make The World'. Sound like you? Join our top-notch team of more than 50,000 diverse and high-performing professionals globally who are making their mark on some of the world's most beloved brands, including DEWALT, BLACK+DECKER, CRAFTSMAN, STANLEY, CUB CADET, and HUSTLER®. The Job: As a compliance engineer, you'll be part of our SAT team working as a hybrid employee. You'll get to: Work with Produ...

Job Description Job Title: Regulatory Affairs Excellence Specialistu00A0 Job Responsibilities Implements global regulatory strategies and roadmaps by leveraging a comprehensive understanding of the competitive market landscape and product marketing strategy to ensure alignment with organizational objectives. Works under general supervision and broad guidelines, consistently exercising independent judgment on matters of significance, ensuring adherence to company policies and regulatory requirements while maintaining high standards of performance and accountability. Demonstrates substantial understanding of regulator's role in the Quality System with good awareness of product lines, disease s...

You will be joining Nivo Controls as a Senior Engineer in the R&D department, responsible for product development. The role will involve designing and developing process control instruments, verifying and validating products, and working on embedded product development. You will also be responsible for implementing international standards, project planning, PCB layout development, technical documentation, and coordinating with other departments. Key Responsibilities: - Design and Development of Process Control Instruments - Design Verification and Validation of Products - Embedded Product development - Implementation of International Standards including EMI/EMC, General Safety, CE Marking, a...

As a member of our team, you will be responsible for designing and developing process control instruments, as well as verifying and validating products. Your role will involve working on embedded product development and ensuring compliance with international standards such as EMI/EMC, General Safety, CE Marking, and Flameproof requirements. You will be involved in project planning, scheduling, and execution, as well as coordinating with various departments within the organization. Additionally, you will be responsible for PCB layout development using EAGLE software and creating technical documentation. The ideal candidate for this position should have a BE/BTech/MTech degree in Electronics, ...

Record all transactions accurately in compliance with accounting principles and reconcile accounts Preparing and entering invoices, bills, checks etc. Assisting with taxation including filing returns of GST/TDS Assisting with preparation of MIS, balance sheets, income statements and other reports Knowledge of regulatory compliance and accounting principles Proficiency in accounting software (tally) and MS Suit (in particular MS Excel) Open to learning ZOHO Quickbooks

Our Client is seeking an experienced Vice President Manufacturing to lead high-precision manufacturing operations, drive innovation in medical device production , and ensure world-class operational efficiency . The ideal candidate will possess deep expertise in micro-precision components, electronics manufacturing, and regulatory compliance for medical devices . Key Responsibilities: Vice President Manufacturing (Medical Devices & Micro Precision Components) Location: Chennai Oragadam Factory Experience Required: 18 to 25 years Industry: Medical Devices, Micro Precision Components, Electronics Manufacturing Manufacturing Leadership: Oversee end-to-end manufacturing operations for medical dev...

Job Description Core Skills 15+ years of hands-on software development experience, with 3-5 years in a senior/principal architect role. Proven expertise in C# .NET and/or Java. Flexibility to work across both technologies is strongly preferred. Solid experience in backend architecture including system design patterns, cloud infrastructure, scalability, and reliability. Proficient in cloud-native architectures using AWS (preferred). Experience with Azure or GCP is a plus. Strong foundation in software design principles, design patterns, and clean architecture. Demonstrated experience designing and implementing complex, multi-generation software products. Deep understanding of Healthcare softw...

JOB DESCRIPTION: Job Title: Regulatory Affairs Specialist - Medical Devices Location: New Delhi Department: Regulatory Affairs Reports To: Regulatory Affairs Manager Job Summary: The Regulatory Affairs Specialist is responsible for ensuring that medical devices comply with all applicable regulations in India and international markets. This role involves preparing and submitting regulatory documents, maintaining compliance with CDSCO and other global regulatory bodies, and supporting product development teams with regulatory guidance. Key Responsibilities: Prepare, compile, and submit regulatory dossiers for product registrations, renewals, and amendments to CDSCO and other regulatory authori...

Role: Quality Manager Medical Devices / Pharmaceutical Products Location: Chennai, Tamil Nadu Job Description: We are seeking a skilled Quality Manager to join our team in the medical devices/pharmaceutical sector. The position requires strong experience in quality management systems, regulatory compliance, and cross-functional collaboration across development and manufacturing. Key Responsibilities: Support multiple quality projects across development and commercialization stages Maintain and enhance QMS in line with ISO 13485, 21 CFR Part 820, EU MDR Review technical documentation (DHF, risk files, validation records) Assist in regulatory submissions (510(k), CE marking) Collaborate with c...

As a Lead QMS at Ai Health Highway, you will play a crucial role in implementing Quality Management System (QMS), ISO13485, EU MDR, and US FDA (510k) Risk Management processes for our cutting-edge medical devices. Your responsibilities will include creating device master records, updating technical documentation, and collaborating with internal and external stakeholders to establish a robust quality management and regulatory framework for our product pipeline. You will work closely with engineering and manufacturing teams to develop verification test strategies to ensure the safety and reliability of our products. Additionally, you will be involved in developing product requirements, support...

About Us We are a global climate technologies company engineered for sustainability. We create sustainable and efficient residential, commercial and industrial spaces through HVACR technologies. We protect temperature-sensitive goods throughout the cold chain. And we bring comfort to people globally. Best-in-class engineering, design and manufacturing combined with category-leading brands in compression, controls, software and monitoring solutions result in next-generation climate technology that is built for the needs of the world ahead.? Whether you are a professional looking for a career change, an undergraduate student exploring your first opportunity, or recent graduate with an advanced...

As a Documentation & Certification Engineer at SPX FLOW located in Pune, you will play a crucial role in ensuring that all products meet global regulatory requirements, with a specific focus on ATEX, Machinery Directive, and CE Marking compliance. Your responsibilities will include creating, managing, and maintaining technical documentation, certification records, and regulatory submissions. You will collaborate closely with engineering, product development, and quality teams, as well as external notified bodies. Your duties will involve preparing and maintaining comprehensive technical documentation such as Declarations of Conformity, instruction manuals, technical construction files, datas...

Mega Virtual drive for Compliance Engineer for Bangalore location Experience : 5 - 10 Years Work Location : Bangalore No of Positions : 5 Roles & Responsibilities: BE/ ME in Mechanical Engineering with 5 - 10 years of experience in the product compliance with various product regulatory or certification agencies. Should have knowledge about the necessity of international certifications like IEC, IECEx, etc and other country regulatory certification like CSA, UL, TUV, Intertek, CE marking, etc. Basic knowledge in the various directives for the EU requirements for the CE marking. Should have basic design Knowledge in the Pressure equipments like Compressors and its accessories. Basic Knowledge ...

Background Industry: Pharmaceutical Formulations (Injectables) or Medical Devices (EU Class 2b or higher) manufacturing company with turnover higher than 300 Cr Required Skills: Experience in QA management across multiple projects involving the implementation of the Company's QA processes and strategies. The projects include IPQA, QMS, cGMP, validation and Compliance related assignments Ensure that the norms and laws, set by regulatory authorities, are met. Preferentially an audit experience for FDA, EU MDR, PMDA, SFDA, TGA and KFDA requirements Excellent knowledge of QA processes including of risk management, clinical data management and electronic data management systems. Ability to handle...

As a Product Assessor, you will play a crucial role in our organization by overseeing Sterilization product assessments and conducting technical file reviews in strict adherence to regulatory requirements, including the European Medical Device Directive and Medical Device Regulation for Class IIa/IIb and/or Class III. Your primary focus will be to ensure the technical soundness of reviews and compliance with all relevant standards. Responsibilities: Conduct comprehensive Sterilization product assessments in line with regulatory requirements for medical devices. Support CE marking activities conducted by SGS, contributing to the overall certification process. Effectively communicate with coll...

As a Product Assessor you ll conduct technical file reviews to ensure that products are safe and perform as intended in compliance with all applicable requirements including UK and EU medical device regulation. You ll also support CE marking activities and communicate with colleagues and clients regarding product assessment and other activities, working to minimise risks associated with medical device certification. Degree or equivalent experience in medicine, dentistry, biotechnology, engineering or other relevant fields 4+ years of professional experience in the orthopaedic/dental products sector or related fields, covering roles in design, manufacturing, auditing, or research. Crucially, ...

Standards & Codes: ASME Section VIII Div. 1 & 2 ASME Section IX (Welding Qualifications ASME Sec V Welding & NDT: Welding process knowledge (SMAW, GTAW, SAW) WPS/PQR/Welder qualifications Non-Destructive Testing (RT, UT, PT, MT, VT) knowledge Interpretation of NDT results Fabrication & Inspection: Dimensional inspection of shells, heads, nozzles Monitoring fit-up and alignment (e.g., weld mismatch tolerances) Hydrostatic / pneumatic testing procedures Surface preparation and painting/coating inspection Materials: Review of Mill Test Certificates Traceability & material control Handling special alloys (e.g., stainless, Hastelloy) Documentation: Preparing Quality Dossiers / Manufacturers Data ...

1. Maintain the QMS documents on the lines of ISO 13485 and GMP 2. Responsible for control of all levels of documents & their history in accordance with EU MDR 3. Coach and Guide the team to support company goals by : Identifying factors that are critical to prospective and retrospective stability studies Participate in the new product registration/ life-cycle management discussions to provide inputs on the procedure for analysis, mainly validations

Urgent Opening for Compliance Engineer - Hazardous Area Classification Experience : 2 - 7 Years Work Location : Bangalore No of Positions : 2 Bachelors of engineering (BE) in Mechanical/Aeronautical • 3 to 8 years of experience in the field of power plant operation is mandatory • Gas Turbine (GT) Engine operating principles knowledge is Mandatory . Hazardous Area Classification - IECEX Certification • GT Data analysis & Trend analysis experience is advantage • Ability to interact and provide solutions for GT Engine snags is an added advantage • Validation of reports based on established processes for quality and accuracy of content • Quality management within the expected Report publication ...

Position - Marketing Engineer - Product Certification Education - BE/B Tech - Electrical/Electronics/ENTC/Mechanical Experience - 3 to 10 Years Location - Pune Job Responsibilities: Implement marketing ideas on-site for CE marking, ATEX and Functional Safety, Product Identify potential customers through visits to various industrial areas. Generate leads by visits and cold calling Co-ordinate with Sr. Project Leader and support in conversion of lead to sales. Achieve monthly targets Maintain/update funnel of potential clients for Gujarat, Rajasthan & MP. Preference: Should have excellent communication and presentation skills Candidate should be smart, energetic and should be a team player Sho...

Role & responsibilities : ISO 9001/ISO 13485. Manage the Quality Management System. To provide QA support in all quality related matters and to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements. Risk Management & CAPA. Establishing procedures and records as per requirement of standards and regulatory authorities. Responsible for establishing, managing, and implementing Records Management policy, Records. Retention and retrieval procedures are in place. To manage and execute internal and external audit schedules and follow up on action plan, Quality Auditing of External suppliers - maintain an annual auditing program. Regular Internal Quali...