iso 13485 lead auditors
5 days ago
We at Zenith Quality Assessors Pvt. Ltd. ) are appointing Full Time ISO 13485 Medical Device – Quality Management System Auditors (MD-QMS Auditors).
Job Location :
Pune, Maharashtra, India
Qualification :
Bachelor / Master Degree in any of the fields, such as, Biology, Microbiology, Chemistry, Biochemistry, Computer and Software Technology, Electrical, Electronic, Mechanical Engineering, Bioengineering, Human Physiology, Medicine, Pharmacy, Physics or Biophysics
Industrial Work Experience in Active Medical Device Industry :
3-4 Years minimum
Pre-requisites (Recommended) :
Qualified Lead Auditor in ISO 13485:2016
Third Party Audit Experience is preferred.
Zenith is accredited by Indian and International Accredited Bodies for providing ISO 13485, ICMED 13485 & other Management Systems certifications, as per applicability. Additionally, Zenith provides audit and certification services for CE Conformity Assessments in co-operation with Internationally recognized EU Notified Bodies or Product Certification Bodies. For more details, please visit our website @
If interested, please write to us with your updated Resume at - alongwith your current and expected CTC.
If not relevant to you, will appreciate if you could further share this opportunity to any eligible candidate of your reference
-
Lead Electronics Engineer
3 days ago
Pune, Maharashtra, India Innoiq Engineering Full time ₹ 1,04,000 - ₹ 1,30,878 per yearElectronics Engineer Medical Device Product DevelopmentLocation: Pune, Maharashtra, IndiaEmployment Type: Full-TimeExperience Required: 57 years About InnoIQ EngineeringInnoIQ Engineering, a subsidiary of B&W Engineering und Datensysteme GmbH (Germany), excels in research, design, and development of precision medical devices. From concept through regulatory...
-
Lead Embedded Software Engineer
3 days ago
Pune, Maharashtra, India Innoiq Engineering Full time ₹ 1,04,000 - ₹ 1,30,878 per yearJob Title: Embedded Software Engineer Medical Device TechnologyLocation: Pune Department: Engineering / Embedded SystemsEmployment Type: Full Time Company Overview:InnoIQ Engineering, a subsidiary of B&W Engineering und Datensysteme GmbH, Germany, is a leading company specializing in the research, design, and development of innovative medical devices. With...
-
PMS Analyst
2 weeks ago
Pune, Maharashtra, India Cyient Full time ₹ 9,00,000 - ₹ 12,00,000 per yearRoles & ResponsibilitiesConduct post-market data analysis (complaints, adverse events, service reports, literature, vigilance data).Prepare and maintain PMS reports, PSURs, and trend analyses.Support risk management updates and product safety evaluations.Collaborate with cross-functional teams for CAPA and field actions.Ensure compliance with EU MDR, ISO...
-
Project Lead AI
1 week ago
Pune, Maharashtra, India Medsynaptic Full time ₹ 20,00,000 - ₹ 25,00,000 per yearWe are seeking a highly motivated professional to lead and coordinate AI-driven projects in the medical imaging domain. This role requires a unique blend of technical expertise, and project management skills to successfully deliver innovative AI solutions that improve diagnostic workflows and patient outcomes.Role & responsibilitiesDrive end-to-end AI...
-
Hardware Project Lead
2 weeks ago
Pune, Maharashtra, India Syrma Johari Medtech Limited Full time ₹ 15,00,000 - ₹ 25,00,000 per yearCompany DescriptionSyrma Johari MedTech Ltd. (formerly Johari Digital Healthcare Ltd.) is a leading partner for medical device design and manufacturing, helping MedTech companies and fast-growing startups bring innovations to market. With over 45 years of expertise, we deliver end-to-end solutions across the product lifecycle—from design and development to...
-
Lead Auditor
3 days ago
Pune, Maharashtra, India Pharmaace Innovations Full time ₹ 12,00,000 - ₹ 36,00,000 per yearRole & responsibilitiesLead a unified enterprise audit function to protect against risk, boost efficiency, and keep every unit certification ready. Set and execute an end-to-end audit strategy spanning people, processes, tech, infrastructure, legal, and security.Keep all audits aligned with global standards Audits for various certifications pertaining to...
-
Quality and CAPA
3 days ago
Pune, Maharashtra, India Cyient Full time ₹ 15,00,000 - ₹ 25,00,000 per yearRoles and ResponsibilitiesLead and manage CAPA process from initiation to closure.Coordinate root cause investigations and ensure robust corrective actions.Track and report CAPA metrics and trends to management.Drive quality improvement projects and cross-functional collaboration.Ensure timely documentation and regulatory compliance.Facilitate audits and...
-
Lead Internal Auditor
7 days ago
Pune, Maharashtra, India Smart Soource Pune Full time US$ 90,000 - US$ 1,20,000 per yearJob SummaryInternal Audit at the company provides independent and objective assurance and consulting services to management, aimed at enhancing and safeguarding organizational value. The team employs a systematic, disciplined approach to assess and improve the effectiveness of risk management, internal controls, and governance processes, all in support of...
-
Lead Mechanical Engineer
2 weeks ago
Pune, Maharashtra, India Syrma Johari Medtech Limited Full time ₹ 8,00,000 - ₹ 24,00,000 per yearCompany DescriptionSyrma Johari MedTech Ltd., a leading medical device design and manufacturing partner, empowers global MedTech companies and fast-growing startups to bring medical innovations to market. With over 45 years of expertise, the company provides end-to-end solutions across the product lifecycle, from design and development to contract...
-
Quality Control Team Lead B I
2 days ago
Pune, Maharashtra, India Eyeglobal Full time ₹ 12,00,000 - ₹ 36,00,000 per yearLocation: TalawadeQualifications: Bachelors degree in Electronics Engineering or a related technical field (Master's preferred).Experience:15+ years of experience in quality management, preferably in electronics manufacturing.Strong knowledge of electronic components, PCBA manufacturing, and testing processes.Experience with regulatory and quality standards...