Quality Systems Compliance Engineer II

Terumo•Davie, FL

About The Position

Quality Systems Compliance Engineer II supports and enhances the Quality Management System (QMS) to ensure compliance with applicable regulatory requirements and industry standards. This role serves as a cross-functional compliance subject matter expert, driving quality system improvements, regulatory alignment, and effective execution of quality processes.

Requirements

B.S. degree or equivalent in Engineering or Scientific discipline required or relevant experience with equivalent combination of education and experience.
3-5 years' overall experience required with at least 3 years of related experience in medical devices/diagnostics, pharmaceutical or other regulated industry required with a focus on product or production, or quality-related responsibilities preferred
Familiarity with FDA, ISO 13485, EU MDR, and multi-country Quality Systems requirements.
Ability to identify and recognize how the standards & regulations potentially affect the wider business of the company
Ability to use process development tools (ex. Lean Six Sigma)
Ability to apply a practical level of statistics. Ability to develop and maintain spreadsheets, pivot tables, metrics, statistical applications, charts/graphs, and user-friendly reports
Strong interpersonal skills to provide coaching, training, and direction with all levels of the organization
Strong proofreading and writing skills, as well as exemplary attention to detail
Strong decision-making including the ability to rapidly understand complex changes and pace work completion to the needs of the company.
Demonstrated initiative and ability to work independently while handling multiple tasks

Responsibilities

Lead the evaluation of new and revised regulations and standards to assess impact on products and QMS processes
Maintain expertise in applicable global regulations and standards, including FDA 21 CFR 820, ISO 13485, ISO 14971, EU MDR/MDD, and Health Canada requirements
Support implementation of regulatory changes through updates to QMS procedures, forms, and processes
Coordinate HHE activities with cross-functional stakeholders (e.g., Medical, PMS) to ensure timely completion
Assist in preparation and execution of Critical Action Committee meetings
Assist in the coordination of recall-related activities as directed
Act as an independent reviewer to ensure compliance issues are properly evaluated, investigated, and resolved
Monitor QMS performance and compliance activities across departments, identifying trends and areas of risk
Serve as a Quality and compliance SME on cross-functional projects (e.g., New Product Development, sustaining engineering, acquisitions)
Perform independent reviews of design control activities to ensure compliance with internal procedures and external regulations
Provide guidance on quality system requirements and regulatory expectations
Perform other duties as assigned
Maintain audit readiness through ongoing training and knowledge of audit requirements
Support external audits (e.g., FDA, Notified Bodies, customers) by preparing documentation and participating in audit activities.