Description

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

This role is on-site.

Responsibilities

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

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.
• 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.
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Outlook).

Key Skills

Education

Bachelor's degree