FULL-TIME | HYBRID
Boulo is recruiting for a SaMD Quality Assurance Lead in the Birmingham area to join our client, a leading IT firm that utilizes artificial intelligence to simplify and streamline medical patient evaluation. Candidate will implement and oversee the firm's Quality Assurance program, FDA Requirements and Audits.
Employment Type: Estimated 30 hours per week
Flexibility: Hybrid
Pay: $80,000 – $90,000
Professional Experience Requirements:
- Quality Management Systems (QMS) – Experience in developing, implementing, and maintaining a QMS, particularly for Software as a Medical Device (SaMD). Scoping a QMS for SaMD can be a challenge to someone who has not done it before, the ideal candidate has specific specific SaMD QMS experience
- Design History Files (DHF) – Familiarity with creating and maintaining DHFs
- Regulatory Compliance – Experience with FDA regulations (21 CFR Part 820 for medical devices) and understanding of ISO standards (e.g., ISO 13485).
- Audit Experience – Prior experience with internal and external audits, including preparation for FDA inspections.
- QMS Software Proficiency and Experience Validating Software Tools (like Medtech OS)
- Degree in relevant field (life sciences, engineering, regulatory affairs)
- Ideal qualifications include Certified Quality Auditor, Certified Quality Engineer, Regulatory Affairs Certification, ISO 13485 Lead Auditor Qualifications
About Boulo: Don’t let your job search end here. Boulo is a recruiting platform that goes beyond titles and timelines. We help experienced, knowledgeable professionals stand out to hiring managers by showcasing value through a skills-first approach. If you’re tired of being overlooked on other job boards and seeking a new opportunity, join Boulo here: https://boulosolutions.com/