9 Ce Marking Jobs

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 colleagues and clients regarding product assessments and related activities. Work proactively to minimize risks associated with medical device certifications. A degree or equivalent qualification with Microbiology modules or relevant studies (e.g., medicine, pharmacy, engineering, or other related sciences). Four years industrial experience with medical device manufacturing that includes a

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, a minimum of two years should be directly involved in the design, manufacturing, and testing of dental products, or in roles that require a deep understanding of the scientific principles underlying these products or technologies. Prior experience conducting orthopaedic or dental product assessments for a Certification/Notified Body (acting as a Technical Documentation Reviewer) is advantageous Strong communication and stakeholder management skills Professional English Orthopaedic and Dental Device knowledge through designing, manufacturing, or testing of devices in some or all the following areas Non-active osteo- and orthopaedic implants (MDN1102) Prosthetic joint replacements (i.e. knee, hip, shoulder, elbow, wrist, ankle, fingers, etc implants) Artificial spinal disc, spinal cages Bone graft substitute for orthopaedic indications, bone cements, etc Osteosynthesis devices such as orthopaedic nails, screws, plates, etc Non-active dental implants and dental material (MDN1103) Dental implants abutments, Root canal filler, etc Non-active, non-implantable dental material (MDN1209) Etching solutions, Braces, Dental cements

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 Reports Reviewing MDRs, ITPs (Inspection & Test Plans), QAPs Familiarity with project documentation control systems Software & Tools Proficiency with MS Office (Excel, Word) Experience with ERP/QMS systems (SAP, Oracle, etc.) Use of inspection instruments (micrometers, ultrasonic thickness gauges) Core Competencies Strong understanding of pressure vessel manufacturing workflows Ability to read and interpret fabrication drawings Knowledge of welding metallurgy and defects Understanding of calibration systems and control of measuring instruments Soft Skills Attention to detail and record-keeping Strong communication (to interface with clients and third-party inspectors) Problem-solving approach to NCRs and root cause analysis (RCA) Preferred / Desirable ASNT Level II Certification in at least 2 NDT methods Knowledge of ISO 9001 and ASME U-Stamp compliance

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 process • Carrying out Ad-hoc based reporting requests as needed basis Interested Candidates can send the updated resume to fakkrudeen.aliahamed@quest-global.com

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.