QARA Consultant - Diagnostics Software Specialist

QARA Consultant - Diagnostics Software Specialist

We are excited to announce a contract opportunity for an experienced QARA Consultant specializing in diagnostics software within the medical device sector. This role is fully remote and requires proficiency in Spanish, aligning with our commitment to excellent communication standards. The ideal candidate will play a crucial part by ensuring compliance through their expertise in quality assurance regulations specific to diagnostic software.

Key Responsibilities:

• Leverage deep knowledge of ISO13485 and IEC 62304 standards towards effective implementation across various stages of product development.
• Guide clinical performance evaluations and analytic validations under IVDR guidelines, effectively managing documentation processes related to IVDR (In Vitro Diagnostic Regulation).
• Fully integrate Quality Management Systems that meet stringent regulatory requirements while maintaining operational efficiencies throughout the lifecycle of diagnostic products.

Necessary Skills & Experience:

• Spanish Speaking: Ability must be at least working level as this position involves frequent communications requiring fluency.
• ISO13485 Expertise: Deep understanding needed because it's critical for designing compliant systems efficiently.
• 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.
• QMS Implementation Proficiency: Hands-on experience implementing robust quality management systems tailored perfectly according to industry needs.