Purpose of the JobYour roleYou ensure state-of-the-art quality in software development for medical and non-MD applications for optometrists.You operate out of India closely supporting the ZEISS SW development teamYou create, review, and approve the Technical Documentation in conformance with product requirements and for international regulatory approval (e.g., MDR, 21CFR820, IEC 62304, cybersecurity)You are a competent partner for R&D, product management and operations in the evaluation of applicable standards and implementation in SW verification and validationYou participate in the design transfer to suppliers including the related documentationYou play a key role in the change management of the applications and support the change owners in the compliant implementation of the change process throughout the entire product life cycleYou develop risk management strategies for agile SW development (ISO 14971)You participate in complaint and non-conformance management investigation and ensure root cause analysis and documentationYou are responsible for post-market surveillance process activities (PMS, PSUR and PMCF)You contribute relevant KPI for management & quality reviewsYou support internal and 3rd party audit activitiesYou support the introduction and implementation of digital platforms for design and QMS processesRequirementsEducation:You have a Bachelor's or Master's degree with a technical orientation or a comparable relevant disciplineWork Experience:5+ years of experience in the development and advancement of quality management and quality improvement measures, ideally in the field of medical software

At least 3 -7 years of work experience in the field of Ophthalmology / healthcare / Consumable portfolio Result orientation & strong strategic & commercial acumen.Excellent analytical and conceptual skills, coupled with a data-driven mindset.Positive attitude and passion that energizes customers and colleagues alikeTrack and review pipeline, sales forecasts, and achievement vs. target; support cluster leader with course correction wherever required.Closely review sales funnel and ensure success with detailed planning and strong execution methods.Preparation of Sales Forecasts, rolling forecast, etc. for the territory/area & ensure execution as per plan.