iso 13485 lead auditors

Electronics 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...

Job 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...

Roles & 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...

We 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...

Company 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...

Role & 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...

Roles 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...

Job 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...

Company 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...

Location: 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...