Job Summary

A diversified technology company has an open position for a Remote Quality Post Market Surveillance Lead.

Core Responsibilities of this position include:

• Overseeing of NAM Market Complaint Handling Intake processes, including monitoring of KPIs and removing barriers to complaint closure
• Leading initiatives to improve complaint intake content quality, partnering with service, Customer Call Center, and addressing Business needs
• Leading efforts globally to drive clarity to escalations and inconsistencies in Business approach to complaint handling processes

Qualifications Include:

• US work authorization
• 7+ years’ experience in quality and regulatory environment focused on 21 CFR 820 and ISO 13485 especially in the function of Post Market Surveillance
• 3+ years working experience in complaint handling
• Experience supporting audits and defending processes to regulators
• Demonstrated comfort in leading large-scale problem-solving workshops/initiatives
• Strong experience in packaging information into a professional, organized method to drive informed decision-making.