QA/RA Specialist – Clinical Digital Pathology

About the role

We are looking for a QA/RA Specialist to join Deciphex’s Diagnexia team, supporting clinical digital pathology operations across the United States and Canada. The role is hybrid, based in Naperville with 2‑3 days per week on site at the Chicago laboratory.

Key responsibilities

• Implement and maintain procedures to meet OIG, CLIA, CAP, FDA, HIPAA and GDPR regulations, ensuring data integrity and inspection readiness.
• Lead internal quality audits, vendor audits, CAPA management, change control and risk register maintenance.
• Coordinate validation activities for new clinical workflows, scanners and AI‑enabled software, preparing protocols and validation reports.
• Prepare and submit regulatory dossiers for US and Canadian digital pathology products, including FDA 21 CFR 820 and Canada CAP/SCC submissions.
• Monitor regulatory changes, conduct gap analyses and maintain the global regulatory requirements database.

Required profile

• Bachelor’s degree in Life Sciences, Clinical Laboratory Science, Computer Science or related field.
• Minimum five years of experience in quality assurance and/or regulatory affairs within a regulated life‑science or medical‑device environment.
• Strong knowledge of US laboratory regulations (CLIA, CAP) and FDA regulations for clinical digital pathology.

Required skills

• CLIA (42 CFR 493) and CAP accreditation processes.
• FDA 21 CFR 820 quality system requirements.
• HIPAA and GDPR privacy and security compliance.
• ISO 13485 and ISO 15189 quality management standards.
• Experience with Software as a Medical Device (SaMD) and AI‑enabled digital pathology solutions.