Job Description for QARA Consultant - Diagnostics Software Specialist
We are seeking a highly experienced QARA Consultant to specialize in diagnostics software within the medical device sector. This contract opportunity is fully remote and requires proficiency in Spanish, reflecting our commitment to excellent communication standards. The ideal candidate will play a crucial part in ensuring compliance through their expertise in quality assurance regulations specific to diagnostic software.
Main Responsibilities:
1. Leverage in-depth knowledge of ISO13485 and IEC 62304 standards for effective implementation across various stages of product development.
2. Guide clinical performance evaluations and analytic validations under IVDR guidelines, effectively managing documentation processes related to IVDR (In Vitro Diagnostic Regulation).
3. Fully integrate Quality Management Systems that meet stringent regulatory requirements while maintaining operational efficiencies throughout the lifecycle of diagnostic products.
Necessary Skills & Experience:
1. Spanish Speaking: Ability must be at least working level as this position involves frequent communications requiring fluency.
2. ISO13485 Expertise: Deep understanding needed because it's critical for designing compliant systems efficiently.
3. IEC 62304 Knowledge: Requires familiarity since you'll need skills applying these international standard engineering techniques specifically suited toward medical device software integration tasks like coding or testing phases.
4. QMS Implementation Proficiency: Hands-on experience implementing robust quality management systems tailored perfectly according to industry needs.