Quality Systems Engineer, Senior

The Quality Systems Engineer, Senior is a top-level leader, developing and supporting the company’s Quality Management Systems, ensuring adherence to domestic and international regulations and company policies., * 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:
• Oversees CAPA system, including maintenance, development and system validation.
• Develops and facilitates 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.
• Operates as lead Subject Matter Expert during internal/external audits and inspections..
• Product/Process Nonconformance:
• Oversees NC system, including maintenance, development and system validation.
• Supports cross-functional teams with investigations, root cause analysis, escalation decisions, and dispositions.
• Operates as lead Subject Matter Expert during internal/external audits and inspections.
• Product Corrections and Removals:
• Oversees the process for product event escalations, health hazard evaluation, and execution of product corrections and removals.
• Provides guidance and drives cross-functional collaboration to make timely decisions, based upon product risk.
• Supports cross-functional teams with investigations, root cause analysis, escalation decisions, and final decisions.
• Operates as lead Subject Matter Expert during internal/external audits and inspections.
• Training and Cross-Functional Responsibilities:
• Oversees 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.
• Monitors Quality Systems training curricula for completeness, appropriateness and execution.
• Responsible for the reporting of LMS system KPIs during Quality Systems Governance and Management Review.
• Operates as lead Subject Matter Expert during internal/external audits and inspections.
• Data Analytics & Reporting Responsibilities:
• 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.
• Facilitates Quality Systems Governance and Management Review meetings in accordance with company procedures.

• Bachelor’s Degree in Engineering or related science from an accredited institution required; Master’s Degree preferred., * Minimum of 6 years full-time medical device engineering/quality/regulatory technical experience. This experience shall be 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.
• Professional Certification through the American Society for Quality (ASQ) or equivalent in Auditing for Medical Devices.
• Experience in software validation, operating within a Quality Management System

Functional/Technical Knowledge, Skills and Abilities Required:

• Demonstrated ability to lead cross-functional teams and project
• Demonstrated ability to communicate effectively 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.