Quality Engineer

Net2Source Inc. is an award-winning total workforce solutions company recognized for its accelerated growth and global operations. They are seeking a Senior Quality Engineer to manage CAPA records, ensuring compliance with global procedures and supporting cross-functional teams in quality assurance activities.

Responsibilities:

• 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

Requirements:

• 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
• Working knowledge of CAPA processes, root cause analysis, and quality system requirements
• 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
• 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
• 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
• Medical device or other regulated industry experience preferred
• 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