What You Can Expect

How You'll Create Impact

• Develops and maintains tools for capture, analysis, and tracking of complaint data.
• Support activities for complaint processing, such as technical investigation, review, regulatory reporting (MDR, MDV).
• Assists sites with response plans to FDA and Notified Body (NB) audit findings
• Collaborates with Corporate Quality staff in capture and analysis of findings for KPI metrics and Management Review
• Proactively works to ensure that quality systems and processes across Zimmer are effective and compliant to all applicable Post Market regulations and standards.
  

What Makes You Stand Out

• Possesses a broad business perspective, including understanding of Zimmer business structure and product realization processes across the enterprise
• Must work well with others and interact effectively with all organizational levels, outside contacts and support personnel.
• Must be creative in solving problems and assisting sites with developing effective corrective action plans.
• Must possess an in depth understanding of Gx P regulations, Post Market Surveillance and reporting regulations, and the function of quality systems
• Must be able to effectively communicate in both oral and written formats.

Your Background

• Bachelor’s degree in an appropriate engineering, technical, or healthcare discipline, or bachelor degree with relevant experience
• Knowledgeable of FDA regulations and applicable ISO standards.
• 5-7 years plus quality or regulatory work experience in an FDA regulated industry required.
• Previous experience in a Post Market Surveillance role a plus.

Travel Expectations