Quality Systems Specialist

We’re seeking an experienced Quality Systems Specialist III to support and continuously improve our Quality Management System (QMS) in a regulated medical device environment. This role will lead QMS initiatives, manage CAPAs, support internal and external audits, maintain regulatory compliance, and partner cross-functionally to drive quality and process improvements. Key Responsibilities Maintain and improve the Quality Management System (QMS) Lead CAPA, non-conformance, and root cause investigations Coordinate FDA, ISO 13485, and EU MDR audits and inspections Develop and maintain SOPs, work instructions, and controlled documentation Track quality metrics and support Quality Management Reviews Partner with Manufacturing, R&D, Regulatory, and Supply Chain to ensure compliance Qualifications Bachelor’s degree in Engineering, Life Sciences, or related field 5+ years of Quality Assurance experience in the medical device industry Strong knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR, and CAPA Experience with QMS software such as MasterControl or Veeva Excellent communication, problem-solving, and audit management skills #J-18808-Ljbffr