Join Our Team at Zenith Quality Assessors Pvt. Ltd., Pune, Maharashtra, India Zenith Quality Assessors Pvt. Ltd., Vimannagar, Pune is registered as an “Indian Notified Body” for Indian Medical Device Rule (MDR) 2017 under Central Drugs Standard Control Organization (CDSCO). We are also an Internationally Accredited Third Party Audit and Certification Body providing Management Systems certifications for different Standards / Schemes (ISO 9001, ISO 13485, ICMED 13485, ICMED 13485 Plus, etc.). Additionally, Zenith provides audit and certification services for CE Conformity Assessments in co-operation with Internationally recognized EU Notified Bodies & Product Certification Bodies. To know more about us, please visit www.zenith-worldwide.com Position Available : ISO 9001 QMS Lead Auditor Qualification : Bachelors / Masters Degree in Engineering (Mechanical, Electrical, Electronics) Work Experience : Minimum 2 years and Maximum 4 years in Engineering Industry (i.e. Manufacturing, QA/QC, Regulatory Affairs Departments). Pre-requisite : ISO 9001 Quality Management System Lead Auditor Certificate. Second Party / Third Party Audit Experience preferred Location : Pune If interested, please write to us with your updated Resume at certification@zenith-worldwide.com alongwith Current/Expected CTC. If not relevant to you, will appreciate if you could further share this opportunity to any eligible candidate of your reference
ISO 13485 MD-QMS Lead Auditor 📍 Location: Pune, Maharashtra 📌 Position Type: Full-time Qualification: • Bachelor’s or Master’s Degree in Engineering or Science (Mechanical, Electrical, Electronics, Biomedical, Biotechnology and any other relevant field) Experience: • 3 to 4 years of experience in the Engineering industry (Preferred departments: Manufacturing, QA/QC, or Regulatory Affairs) Essential Requirements: • ISO 13485 Lead Auditor Certificate (QMS for Medical Devices) • Second-party or third-party audit experience (preferred) ________________________________________ How to Apply: 📩 Send your updated resume along with your Current and Expected CTC to: certification@zenith-worldwide.com 📣 If this role isn't a match for you, we’d greatly appreciate it if you could share this opportunity with a suitable candidate from your network.
We at Zenith Quality Assessors Private Limited (A Certification & Notified Body, www.zenith-worldwide.com) have an opening for ISO 13485 Auditor. Knowledge of ISO 13485 is mandatory. Job Description: To deal with all technical operational matters ( i.e. Application and Contract Review, TCF / Medical Device File Review, On-site Assessments / Audits) related to ISO 9001, ISO 13485, ICMED 9000, ICMED 13485, MDR 2017 Approval, CE Mark Certification (Medical Devices and In-Vitro Diagnostic Medical Devices ) with present and potential clients. The scope is from the Application stage to the Audit and Certification stage including post certification services i.e. surveillance activities including surveillance audits. Please note, the maximum budget for this opportunity is fixed at CTC 4.0 Lakhs for min. 4 years of work experience. If less experience, an increment of max @ 10% on the existing CTC will be considered taking into account the time of investment from our side to upgrade you to the Auditor level. If interested, please share your profile @ certification@zenith-worldwide.com alongwith current CTC. Also, if you happen to know someone who fits the above criteria and may be interested, we would appreciate it if you could connect them to us.