Work Location: Miami-Dade County, Florida

Summary:

Seeking a Quality Engineering professional to support compliance and manufacturing quality functions in a regulated medical device environment. The role involves ensuring adherence to FDA and ISO 13485 standards, supporting production, and driving continuous improvement initiatives.

Responsibilities:

• Lead investigations and resolutions for complaints, nonconformances, and CAPA activities, ensuring effective containment and corrective actions.
• Assess events for complaint and reportability status, and complete required Medical Device Reports in line with regulatory standards.
• Drive risk management processes, including hazard analysis, FMEAs, and risk-benefit assessments in accordance with ISO 14971.
• Recommend and revise quality assurance policies and procedures to align with evolving regulatory requirements and best practices.
• Create and present monthly quality dashboards, highlighting trends in nonconformances and production yields to leadership.
• Design or specify inspection and testing mechanisms to monitor product quality throughout the manufacturing process.
• Support manufacturing and quality control teams to ensure successful product release and compliance with standard operating procedures.
• Participate in regulatory inspection support, including preparing correspondence and documentation for global regulatory agencies.

Qualifications:

• Bachelor’s degree in Biomedical Engineering or a related field from a four-year college or university.
• Minimum of 1 year of experience in a Quality Assurance role within a regulated industry.
• Experience in a small start-up environment is highly desirable.
• Strong understanding of Quality Management Systems, 21 CFR 820, CE Mark, and ISO 13485 standards.
• Ability to comprehend and document complex technical information.
• Excellent communication skills, strong attention to detail, and ability to work collaboratively in a team environment.
• Proficiency with computers and related software applications.
• Engineering experience in medical device development is an advantage.
• Project or team leadership experience is a plus.
• Ability to read, analyze, and interpret scientific and technical journals and standards.
• Skilled in presenting information effectively to both internal and external stakeholders.

Published Category: Quality & Validation