130520 - Quality Engineer I
Core
Perform complaint investigations for Cardiac Ablation Solutions products and support test method validation activities.
Role type
Entry-level individual contributor Quality Engineer
Builds
Inspection and testing procedures for returned medical devices
Domain
Medical device manufacturing (Cardiac Ablation Solutions)
Deliverable
client delivery
Required skills
Statistical methodologies, Quality Management Systems (QMS), document control, nonconformance management, CAPA, change management, Microsoft Office Applications, Windows OS
Preferred skills
Biomedical/Mechanical/Electrical Engineering background, FDA 21 CFR Part 820, EU MDR, ISO 13485, ISO 14971, IEC 60601
Technologies
Microsoft Office (Word, Excel, Access, PowerPoint), Windows OS
Responsibilities
Perform complaint investigations for Cardiac Ablation Solutions products, Collaborate with engineering team to escalate risk file signals, Devise and implement methods for inspection and testing of returned product, Support test method validation activities, Apply statistical methodologies, Provide training to technicians
Seniority
Entry-level, works with close supervision