JOB SUMMARY

We are seeking a knowledgeable and detail-oriented part-time Configuration Manager to join our dynamic team. The qualified candidate will act as a key liaison between the software development and quality/regulatory teams. This role is responsible for establishing and maintaining our software development processes to ensure they meet the requirements of our Quality Management System and relevant medical device regulations, including IEC 62304 and ISO 13485. The specialist will manage configuration, oversee the validation of all internal and third-party software, and ensure full traceability of all software artifacts. This position is essential for ensuring our SaMD products are safe, effective, and compliant.

QUALIFICATIONS

• Procedural Knowledge: Must demonstrate a strong understanding of quality system procedures for SaMD.
• Technical Proficiency: Must be proficient in using software development tools like Git, Jira.
• Regulatory Competence: Must have a solid grasp of medical device software regulations (IEC 62304, ISO 13485).
• Continuous Improvement: Expected to maintain and enhance skills through ongoing training and professional development.
• Experience: 5 years in a software development or quality assurance role within a regulated industry.
• Knowledge: Expertise in configuration management, software validation, and the handling of SOUP/OTS software.
• Skills: Excellent communication, strong attention to detail, and a methodical approach to process management.
• Education: Bachelor’s degree in a relevant field (Computer Science, Engineering, Quality Assurance).
  This is an office-based, part-time role, which may involve remote work options as per company policy. The role requires collaboration across multiple departments.
  Join us as we strive for excellence in our operations through effective configuration management!
  Job Type: Part-time
  Pay: $35,000.00-$55,000.00 per year
  Expected hours: 20 per week

Benefits:

• On-site parking

Work Location: In perso

• Configuration Management: Develop and enforce a configuration management plan for all software development activities, including version control, change control, and release management.
• Software Validation: Create, execute, and maintain validation protocols for all internal software used in our QMS.
• SOUP/OTS Management: Identify, risk-assess, and validate all Software of Unknown Provenance (SOUP) and Off-the-Shelf (OTS) software and maintain a Software Bill of Materials (SBOM).
• Regulatory Compliance: Ensure all software development processes, from requirements to testing, comply with our QMS and medical device standards (IEC 62304, ISO 13485).
• Traceability: Establish and manage the traceability matrix linking requirements, design, code, tests, and risk analysis.
• Audit Support: Participate in internal and external audits by providing evidence of our configuration, validation, and compliance activities.
• Training & Mentoring: Train the software development team on compliance procedures and the proper use of development tools.