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.
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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.
Education:
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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. 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.
