QMS Specialist

Job Description

Job Description

Job Title: QMS Specialist

Office Location: Miami, Florida

Position Summary :

The QMS specialist is responsible for support for InspireMD QMS processes. This includes inspecting product, supporting and monitoring effectiveness of non-conformances, deviations, audits findings, training activities, document control and CAPAs. You will be responsible for ensuring product compliance with FDA regulations, ISO 13485 standards, and other applicable regulatory requirements. The ideal candidate will have strong experience in the medical device industry and a solid understanding of quality processes.

Essential Duties and Responsibilities :

• Assist in the development, implementation, and ongoing maintenance of the Quality Management System (QMS).
• Perform product receiving and shipment inspection.
• Support both internal and external audits to assess regulatory compliance and identify areas for continuous improvement.
• Review, update, and develop Standard Operating Procedures (SOPs) as necessary to ensure alignment with quality standards.
• Assist with document control activities, ensuring accuracy and proper handling of documentation.
• Coordinate and oversee non-conformance investigations, ensuring thorough analysis and resolution.
• Manage and support Corrective and Preventive Action (CAPA) processes, including review and approval of CAPA plans as required.
• Coordinate and track deviation management processes, ensuring timely resolution and documentation.
• Develop and monitor training plans for new employees, ensuring compliance with required training programs.
• Lead and/or assist in training sessions for both new hires and existing employees to ensure understanding of quality practices.
• Maintain detailed records and reports on quality metrics, trends, and performance to drive continuous improvement initiatives.

Qualifications :

• Bachelor’s degree in science, engineering or related field
• 5+ years of experience in a Quality role within a medical device industry.
• Strong problem-solving skills with the ability to conduct root cause analysis and implement corrective actions.
• Strong understanding of quality management systems, regulatory requirements, and industry best practices.
• Strong communication skills, both written and verbal.
• Detail-oriented with the ability to manage multiple tasks and meet deadlines.
• Ability to work independently and collaboratively in a small team environment.

Preferred Qualifications:

• Certification as a Quality Auditor (CQA) or other relevant certification is a plus.

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.