Quality Systems Engineer, Senior

About the role

The Quality Systems Engineer, Senior is a top-level leader responsible for developing and supporting the company’s Quality Management Systems, ensuring adherence to domestic and international regulations and company policies.

Responsibilities

• Quality Systems and Regulatory Compliance:
  • Know and apply the Quality System and any appropriate Federal and International standards (FDA, ISO 13485, MDSAP, EU MDR, etc.).
  • Provide leadership and strategy for the team in the overall administration and maintenance of the QMS processes, ensuring alignment with organizational goals.
  • Ensure that Quality Management Systems documentation meets the required guidelines for maintaining FDA compliance and ISO/EC/MDR certification.
  • Support the strategic initiatives of the company to achieve and maintain regulatory compliance.
• Corrective and Preventive Action (CAPA):
  • Oversee the CAPA system, including maintenance, development, and system validation.
  • Develop and facilitate continuous training and development for the CAPA process, including root cause analysis and verification of effectiveness.
  • Responsible for the reporting of CAPA system KPIs during Quality Systems Governance and Management Review.
  • Operate as lead Subject Matter Expert during internal/external audits and inspections.
• Product/Process Nonconformance:
  • Oversee the NC system, including maintenance, development, and system validation.
  • Support cross-functional teams with investigations, root cause analysis, escalation decisions, and dispositions.
  • Operate as lead Subject Matter Expert during internal/external audits and inspections.
• Product Corrections and Removals:
  • Oversee the process for product event escalations, health hazard evaluation, and execution of product corrections and removals.
  • Provide guidance and drive cross-functional collaboration to make timely decisions based on product risk.
  • Support cross-functional teams with investigations, root cause analysis, escalation decisions, and final decisions.
  • Operate as lead Subject Matter Expert during internal/external audits and inspections.
• Training and Cross-Functional Responsibilities:
  • Oversee the Learning Management Solution (LMS), including maintenance, development, and system validation.
  • Develop training and competency solutions to meet the needs of the company and its Quality Management System.
  • Monitor Quality Systems training curricula for completeness, appropriateness, and execution.
  • Responsible for the reporting of LMS system KPIs during Quality Systems Governance and Management Review.
  • Operate as lead Subject Matter Expert during internal/external audits and inspections.
• Data Analytics & Reporting:
  • Assist with the development of training materials and documentation to ensure effective dissemination of knowledge to team members and stakeholders.
  • Responsible for compiling process data for presentation during Quality Systems Governance and Management Reviews.
  • Facilitate Quality Systems Governance and Management Review meetings in accordance with company procedures.

Requirements

• Education: Bachelor’s Degree in Engineering or related science from an accredited institution required; Master’s Degree preferred.
• Experience:
  • Minimum of 6 years full-time medical device engineering/quality/regulatory technical experience (in addition to any college internships). Relevant experience in other areas may be considered.
  • Experience in Change Management documentation systems preferred.
  • Experience in electronic Quality Management Systems solutions (e.g., SmartSolve IQVIA, Cornerstone, Teamcenter).
  • Experience in data management and reporting utilizing PowerBI.
• Certifications: Professional Certification through the American Society for Quality (ASQ) or equivalent in Auditing for Medical Devices.
• Functional/Technical Knowledge, Skills, and Abilities:
  • Demonstrated ability to lead cross-functional teams and projects.
  • Demonstrated ability to communicate effectively in quality-related discussions.
  • Experience with the development, implementation, and maintenance of electronic solutions for Quality Management Systems elements such as CAPA, Audits, Data Analysis, etc.
  • Demonstrable knowledge of all domestic and international Quality System regulations.
  • Experience in software validation, operating within a Quality Management System.

Location: Gainesville, FL