PQL Specialist

Purpose of the Job

Your role

• You 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 team
• You 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 validation
• You participate in the design transfer to suppliers including the related documentation
• You 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 cycle
• You 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 documentation
• You are responsible for post-market surveillance process activities (PMS, PSUR and PMCF)
• You contribute relevant KPI for management & quality reviews
• You support internal and 3rd party audit activities
• You support the introduction and implementation of digital platforms for design and QMS processes

Requirements

Education:

• You have a Bachelor's or Master's degree with a technical orientation or a comparable relevant discipline

Work Experience:

• 5+ years of experience in the development and advancement of quality management and quality improvement measures, ideally in the field of medical software