SW QMS Specialist

Job Description: Qualifications: • Bachelor's degree in Quality Management, Regulatory Affairs, Life Sciences, or a related field. • Minimum of 5 years of experience in QMS, quality assurance, regulatory compliance, or related roles. • Software/AI experience. • Strong knowledge of FDA and EU regulatory requirements, specifically with QMS. • Experience with CAPA processes, document management, and regulatory submissions. • Familiarity with cybersecurity audit procedures and standards. • Excellent communication skills, with a keen attention to detail and ability to manage multiple priorities. Preferred Qualifications: • Certification in Quality Management or Regulatory Affairs (e.g., ASQ, RAPS). • Hands-on experience with QMS software systems. • Experience in the medical device or healthcare tech industry.

Created: 2026-03-10