Senior Quality Engineer

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