About Pictor Labs

Pictor Labs is the leading virtual staining company revolutionizing digital pathology adoption worldwide through cutting-edge AI-powered technology. Our solutions deliver diagnostic-quality results in minutes while preserving tissue samples for comprehensive analysis.

Our breakthrough DeepStain™ and ReStain™ technologies enable unlimited virtual staining from a single tissue sample, eliminating the bottlenecks and limitations of traditional chemical staining processes. This innovation supports the critical evolution from research applications to clinical deployment, empowering laboratories to advance their digital pathology capabilities while reducing chemical waste, improving operational efficiency, and expanding diagnostic possibilities.

Position Overview

Pictor Labs is seeking a part-time Software Compliance QA Consultant/Contractor to support and oversee software lifecycle documentation, design control, and regulatory compliance processes for our AI-driven virtual staining platform.

This position will not focus on software testing or writing test cases, but rather on ensuring that the software development and design change processes are compliant with regulatory standards and well-documented across systems such as Ketryx and JIRA.

The consultant will collaborate closely with product, engineering, and the QARA teams to ensure software artifacts—including requirements documents (PRDs, SRS, SDS, etc.), risk management files, and change records—are accurate, traceable, and compliant with IEC 62304 and related standards.

This is a remote, part-time contract role (approximately 10–20 hours per week) reporting to the Director, Quality Assurance and Regulatory Affairs (QARA).

Key Responsibilities

Software Compliance & Design Control

• Partner with engineering, product, and QARA teams to ensure all software design control processes align with IEC 62304 and internal quality procedures.
• Support the development, maintenance, and remediation of key software lifecycle documents, including:
  • Product Requirements Documents (PRD)
  • Software Requirements Specifications (SRS)
  • Software Verification and Validation (i.e. Unit/System/Integration Testing)
  • Software Bill of Materials (SBOM)
  • Software Traceability Matrix
    
• Review and refine documentation to ensure traceability from requirements to verification and validation (V&V) and alignment with risk management files.
• Develop and implement software design change processes in Ketryx with integration in JIRAl, ensuring traceable workflows across all systems.
• Participate in Change Review Boards (CRBs) and collaborate with engineering to ensure that software changes are properly classified, documented, and approved.

Process Development & Improvement

• Assist in defining and improving software development lifecycle (SDLC) processes to meet regulatory and quality system requirements.
• Development of the software design control and design change process in Ketryx.
• Ensure the integrity of software records within the Ketryx platform, including verification of linkages between requirements, risks, and test evidence.
• Establish/maintain software configuration management change control documentation.
• Contribute to the creation and continuous improvement of SOPs, work instructions, and templates related to software lifecycle management.

Cross-Functional Collaboration

• Work closely with engineering, product management, and QARA teams to align documentation practices with internal quality procedures.
• Support the Director, QARA in audit readiness and regulatory submission preparation (e.g., FDA 510(k), CE-IVDR technical files).
• Participate in periodic reviews of software documentation to ensure ongoing compliance with applicable standards and regulations.

Key Skills & Competencies

Must-Have:

• Hands-on experience with requirements management software such as Ketryx to implement software design control / SDLCs, including integration with JIRA.
• Proficiency with JIRA for managing software changes and issue tracking.
• Strong understanding of IEC 62304 and experience ensuring software design control compliance under a regulated QMS (i.e. 21 CFR Part 820, ISO 13485, IEC 62304).
• Demonstrated ability to review and remediate software documentation such as PRDs, SRS, SDS, and related artifacts cross-collaboratively (i.e. with Eng, QA, Product teams).
• Experience partnering with engineering to ensure compliant implementation of design changes to ensure timely software releases with minimal quality issues / defects.
• Experience managing and implementing integrated “systems of systems,” encompassing both regulated and non-regulated components ensuring proper segregation, documentation, and compliance boundaries.
  

Nice-to-Have:

• Familiarity with application of SDLC / design control to digital pathology, AI/ML-based medical devices, or other IVD software domains.
• Experience working in regulated environments such as FDA 21 CFR Part 820, ISO 13485, or EU IVDR, especially for Class II/III SaMDs.
• Experience with Qualio or other eQMS systems, including SOP writing, document control, and process definition.
• Experience supporting internal and external audits related to software design control or documentation compliance.

Qualifications & Experience

• 5+ years of relevant experience in software quality assurance or software compliance within a regulated environment (SaMD or equivalent).
• Strong working knowledge of software lifecycle management, traceability, and documentation control.
• Experience collaborating with Engineering, Product Management, and QARA teams in a cross-functional, remote, and regulated environment.
• Excellent documentation, analytical, and communication skills.
• Proven ability to work independently and proactively in a fast-paced, dynamic setting.

Our Technology Stack

Front-end: React, TypeScript, JavaScript

Back-end: Python, Node.js, Nest.JS

Cloud: AWS services (EC2, S3, Lambda, etc.)

Database: SQL and NoSQL solutions

Testing: Selenium, Jest, and other automated testing frameworks

CI/CD: Docker, Kubernetes, and modern DevOps tools

Location: This position shall be remote with occasional travel to the Los Angeles office as appropriate.

Key Objectives & Milestones

Within 1 Month

• Gain familiarity with design control documentation and software tools (Ketryx, Jira, etc.).
• Review existing software documentation (PRD, SRS, Trace Matrix) for completeness, gaps, and compliance issues.
• Align with Engineering and QA on design control / SDLC priorities and deliverables.
  

Within 2 Months

• Lead remediation of core software design control documents for accuracy, traceability, and regulatory alignment.
• Implement IEC 62304-compliant software development and change control workflows in Ketryx.
• Train cross-functional teams on documentation and change management best practices.
  

Within 3 Months

• Ensure end-to-end traceability across requirements, risk, and verification artifacts.
• Support regulatory submission readiness by validating design control documentation completeness.
• Participate in routine Engineering scrums and change reviews to monitor compliance and maintain release readiness.

Equal Opportunity Statement

Pictor Labs is an equal opportunity employer committed to diversity and inclusion. We celebrate diverse perspectives and are dedicated to creating an inclusive environment where all employees can thrive, regardless of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.