Description

You lead cross-functional teams to find root causes and implement solutions for performance issues in Cardiac Rhythm Management and Diagnostics products.

Responsibilities

• Lead cross-functional teams investigating complex product performance issues where the design is suspected root cause.
• Manage Nonconforming Events and Preventions (NCEPs), Corrective and Preventive Actions (CAPAs), and Field Action recommendations.
• Collaborate with R&D, Regulatory, Marketing, Medical Safety, and Manufacturing to resolve technical issues.
• Create, review, and approve Quality System records for NCEPs and CAPAs, maintaining documentation per Good Documentation Practice.

Required Skills

• 4+ years of relevant experience in the Medical Device industry.
• Bachelor's degree in engineering or a related discipline.
• Knowledge of Quality System Regulations, Medical Device Regulation, and ISO 13485 Quality Standards.
• Experience with non-conforming products/processes, CAPAs, and Field Action decision making.
• Proficiency in using DMAIC, Root Cause Analysis, 5 Whys, and Cause & Effect Diagram.
• Experience leading complex technical problem-solving using methodical techniques.
• Familiarity with Quality System, Capas, and Field Action Decision processes.
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Outlook).

Key Skills

Education

Bachelor's degree