Quality Systems Engineer, Senior

Advita Ortho•Gainesville, FL

5d•Onsite

About The Position

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.

Requirements

Bachelor’s Degree in Engineering or related science from an accredited institution required
Minimum of 6 years full-time medical device engineering/quality/regulatory technical experience. This experience shall be in addition to any college internships.
Experience in electronic Quality Management Systems solutions (e.g. SmartSolve IQVIA, Cornerstone, Teamcenter).
Experience in data management and reporting utilizing PowerBI.
Experience in software validation, operating within a Quality Management System
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.

Nice To Haves

Master’s Degree preferred.
Relevant experience in other areas may be considered.
Experience in Change Management documentation systems preferred.
Professional Certification through the American Society for Quality (ASQ) or equivalent in Auditing for Medical Devices.

Responsibilities

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.
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.
Oversees NC system, including maintenance, development and system validation.
Supports cross-functional teams with investigations, root cause analysis, escalation decisions, and dispositions.
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.
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.
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.