Senior Quality Systems Lead - Medical Devices & CAPA

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 Master Control or Veeva
• Excellent communication, problem-solving, and audit management skills