Jobs

Description

Quality Senior Engineer I

Duties

• Review, remediate, and migrate legacy CAPA records into EtQ to ensure completeness, accuracy, and compliance with global procedures.
• Manage assigned CAPAs through initiation, investigation support, action tracking, effectiveness verification, and closure.
• Perform gap assessments of CAPA records and support correction of documentation deficiencies to meet regulatory and internal quality system requirements.
• Partner cross-functionally with Quality, Regulatory, Operations, and Engineering to support CAPA execution and remediation activities.
• Support compliance to global CAPA procedures, including documentation standards, timeliness expectations, and record retention requirements.
• Assist with training and user guidance related to CAPA procedures and EtQ processes.

Skills

• Working knowledge of CAPA processes, root cause analysis, and quality system requirements.
• Experience with electronic Quality Management Systems (EtQ preferred).
• Knowledge of applicable regulations and standards, including 21 CFR Part 820, ISO 13485, and risk-based quality principles.
• Strong technical writing and documentation review skills.
• Strong organizational skills with high attention to detail and ability to manage multiple priorities.
• Analytical/problem-solving skills with ability to identify gaps and drive resolution.
• Ability to work cross-functionally and communicate effectively across levels of the organization.
• Proficiency with Microsoft Office (Excel, Word, PowerPoint) and document control systems.
• Medical device or other regulated industry experience preferred.

Education

• B.S. in engineering or an alternative Bachelor’s degree program
• 3-5 years of experience required in a Quality Engineering role, preferably supporting CAPA processes
• Knowledge of FDA QSR (21 CFR 820), ISO 13485, and ISO 14971 preferred.
• Knowledge of design controls, risk management, FMEA, CAPA, root cause investigation and statistical analysis.
• Certified Quality Engineer (CQE) and Medical device, particularly Orthopedic industry, experience preferred