9 Ce Marking Jobs

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 Should ready to travel on a daily basis to various parts of region Candidate with his/her own vehicle will be preferred If you are interested share your updated resume on email - pswapnil@tuv-nord.com Thanks & Regards, Swapnil Parbatrao Sr Officer Talent Acquisition (Pune Region) TUV INDIA House, Survey No. 42, Hissa No.3/1 & 3/2, Sus, Tal: Mulshi, Dist: Pune Pincode : 411 021 Email ID : pswapnil@tuv-nord.com

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 Quality Audit and maintain the company anytime audit ready. Participate in and/or lead audits, manage action plans and follow up on agreed upon CAPAs & NCs. To monitor & handle market complaints. Conduct Management review at site. Conduct Calibration of instrument & Maintain Calibration Matrix . Ensure that a respective Change Control procedure is in place and adhered to . Process validation protocol preparation & implementation. Provide leadership and expertise on all aspects of product regulatory compliance to ensure that products are successfully introduced and maintained domestically and globally pursuant to regulatory compliance. Must be capable to handle all types of Audit. To Lead and face the regulatory audits and close all queries and NC in stipulated time. To maintain all documents related to compliances. Create Maintain & update Device Master/ Product Technical File. Preferred candidate profile: Graduate in Science or Engineering . Post Graduation preferred. Thorough Experience in quality and regulatory areas. Thorough experience in ISO 13485, GMP, US FDA, EU MDR, CDSCO, ISO 9001. Regulatory functions throughout the organization including monitoring , improvement , audits, and team building. Thoroughly conversant with technical documentation requirement and preparation. Excellent MS office skills. Should have faced multiple audits from multiple agencies Should have thorough knowledge of the applicable standards Perks and benefits: Medical Insurance for Spouse , 2 Kids Below 18 years upto Rs. 3lac.

Job Summary We are looking for a detail-oriented and experienced Quality Control Engineer to join our manufacturing team. The ideal candidate will be responsible for implementing and overseeing quality control processes, ensuring all products meet national and international medical device standards, and working closely with production and R&D to resolve quality issues. Key Responsibilities Conduct in-process and final quality inspections for medical devices in accordance with GMP and ISO 13485 standards. Develop and maintain QC protocols, SOPs, and inspection reports. Ensure compliance with regulatory requirements such as CDSCO, MDR 2017, ISO 13485, and CE. Perform root cause analysis and corrective/preventive action (CAPA) for quality issues and non-conformities. Liaise with production, QA, and R&D teams to address quality-related challenges. Monitor and analyze data from incoming raw materials, in-process controls, and finished goods. Maintain proper documentation and assist in internal/external audits. Qualifications & Skills Bachelor's degree in Engineering (preferably in Biomedical, Mechanical, or Industrial Engineering). 25 years of experience in a QC role within the medical device or pharmaceutical industry. Strong knowledge of ISO 13485, QMS, GMP, and applicable regulatory standards. Hands-on experience with measurement tools (e.g., Vernier calipers, micrometers, leak testers). Proficiency in documentation and data analysis. Familiarity with cleanroom protocols and sterilization validation is a plus.

About Janitri Janitri is a Med-tech company that develops IoT-based smart pregnancy and newborn monitoring devices. Apart from a recent feature in Shark Tank, Janitri has won numerous awards and accolades for its life-saving innovations. About the position: We are seeking a highly motivated and experienced Senior Regulatory and Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements and maintaining high-quality standards throughout the product lifecycle of Class II medical devices. This role requires a deep understanding of regulatory affairs, quality management systems, and strong attention to detail. Roles and Responsibilities: Regulatory Compliance: Lead regulatory submissions (510(k), Technical Files, Design Dossiers) for Class II medical devices to regulatory authorities (FDA, Notified Bodies, etc.). Interpret and apply regulations (FDA QSR, ISO 13485, MDR, etc.) to ensure compliance of products and processes. Monitor changes in regulations and communicate potential impacts to relevant stakeholders. Quality Management Systems: Develop, implement, and maintain quality management systems (QMS) to ensure compliance with regulatory requirements and industry standards. Conduct internal audits and oversee external audits to assess QMS effectiveness and identify areas for improvement. Manage corrective and preventive action (CAPA) processes to address quality issues and prevent recurrence. Product Lifecycle Management: Provide regulatory guidance and support to cross-functional teams throughout the product life cycle, from product development to post-market surveillance. Review and approve design control documentation, including design inputs, verification/validation plans, and risk management activities. Support regulatory assessments of product changes and design modifications. Compliance Documentation: Prepare and maintain regulatory documentation, including regulatory submissions, technical documentation, and quality records. Ensure documentation is accurate, complete, and in compliance with applicable regulations and standards. Required Skills: Bachelor's degree in a relevant scientific or engineering field; advanced degree preferred. Minimum of 10+ years of experience in regulatory affairs and quality assurance within the medical device industry, with specific experience in Class II devices. In-depth knowledge of FDA regulations (21 CFR Part 820), ISO 13485, and other relevant standards. Experience with regulatory submissions, including 510(k) applications and Technical Files. Strong analytical skills and attention to detail. Excellent written and verbal communication skills. Ability to work effectively in a cross-functional team environment.

Skills & Keywords: Regulatory Affairs | RA Compliance | Medical Devices | Pharma Regulatory | FDA | CE Marking | ISO 13485 | Clinical Research | Quality Assurance | Risk Management

Background Industry: 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, validation and Compliance related assignments Ensure that the norms and laws, set by regulatory authorities, are met. Preferentially an audit experience for 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 adverse events and rectify non conformities reported in inspections

1. Implement and maintain the quality system 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 quality Improving capabilities & increasing stability of process control measures Participate in the new product registration/ life-cycle management discussions to provide inputs on the procedure for analysis, mainly validations

Position - Business Development Manager Education - BE - Electronics/Instrumentation/ENTC Experience - 5 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. If interested share your updated resume on email - pswapnil@tuv-nord.com Thanks & Regards, Swapnil Parbatrao Sr Officer Talent Acquisition – (Pune Region) TUV INDIA House, Survey No. 42, Hissa No.3/1 & 3/2, Sus, Tal: Mulshi, Dist: Pune Pincode : 411 021 Email ID : pswapnil@tuv-nord.com

Diploma or Degree in Engineering (Electrical, Mechanical,Electronics preferred Minimum 2 years of experience in technical sales(CE marking knowledge is a plus) Drive sales of CE marking and product certification services to clients across industries