SW QMS Specialist
Katalyst HealthCares & Life Sciences
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.
Vacancy posted 4 days ago
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