[Hiring] Senior Quality Assurance Analyst @Intelerad

Role Description

The Senior Quality Assurance Analyst (Regulatory Affairs) is responsible for driving quality and compliance excellence across Intelerad’s Software as a Medical Device (SaMD) portfolio. This role combines deep knowledge of medical device quality systems with hands-on execution of core QA/RA processes, including CAPA, audit readiness, supplier oversight, and regulatory support. As a senior individual contributor within the Regulatory Affairs & Quality organization, this role partners cross-functionally to ensure quality and regulatory requirements are embedded throughout the product lifecycle and that Intelerad maintains a state of continuous compliance.

Key Responsibilities

• Quality System Execution & Continuous Improvement
  • Lead and manage Corrective and Preventive Actions (CAPAs), including investigations, root cause analysis, effectiveness checks, and documentation.
  • Drive improvements to the Quality Management System (QMS) in alignment with ISO 13485, FDA 21 CFR Part 820, and applicable global regulations.
  • Author, review, and maintain quality system documentation, including SOPs, work instructions, and forms.
  • Track, trend, and analyze quality metrics to identify systemic issues and improvement opportunities.
  • Collaborate with development teams in an Agile environment to integrate quality practices throughout the software development lifecycle.
  • Participate in continuous learning opportunities including training and conferences to stay current with QA methodologies, emerging technologies, and industry best practices.
• Audit & Inspection Readiness
  • Lead and support internal audits to ensure ongoing compliance with regulatory and internal requirements.
  • Support external audits and inspections (e.g., FDA, Notified Bodies, Health Canada).
  • Coordinate timely responses to audit findings and ensure effective remediation and closure.
• Supplier & Vendor Quality Management
  • Lead supplier qualification, evaluation, and monitoring activities.
  • Ensure supplier compliance with quality agreements and regulatory expectations.
  • Support supplier audits and ongoing performance assessments.
• Regulatory Support
  • Support preparation and maintenance of regulatory submissions and registrations for global markets.
  • Participate in regulatory impact assessments, change control, and product lifecycle activities.
  • Collaborate with Regulatory Affairs leadership to support global compliance strategies.
• Cross-Functional Collaboration
  • Partner with R&D, Product, Clinical, and Operations teams to integrate quality and regulatory requirements into development and operational processes.
  • Provide guidance on risk management (ISO 14971) and design control expectations.
  • Support complaint handling, post-market surveillance, and vigilance activities.

Qualifications

• Bachelor’s degree in a scientific, engineering, or healthcare-related field, or equivalent industry experience.
• 4+ years of experience in Quality Assurance and/or Regulatory Affairs within the medical device industry.
• Demonstrated experience working within a certified Quality Management System (ISO 13485).
• Strong working knowledge of:
  • FDA 21 CFR Part 820 / QSR (and QMSR readiness).
  • ISO 13485.
  • ISO 14971 risk management principles.
• Proven experience managing CAPA, audits, and supplier quality processes.

Requirements

• Strong analytical and problem-solving skills.
• Ability to lead quality initiatives and influence cross-functional stakeholders.
• Excellent written and verbal communication skills.
• Strong organizational skills with the ability to manage multiple priorities.
• Ability to work independently in a regulated, fast-paced environment.

Benefits

• Experience with electronic QMS platforms (e.g., Greenlight Guru or similar).
• Prior experience supporting regulatory inspections.
• Familiarity with global regulatory frameworks (EU MDR, UKCA, Health Canada, TGA, etc.).
• Quality certifications (e.g., ASQ CQE, CQA).
• Experience with Software as a Medical Device (SaMD) or healthcare software a major bonus.