Product Quality Clinician Manager - Remote

Overview

This role focuses on providing medical and clinical guidance in the Quality department to ensure compliance and optimize product development, ultimately improving patient outcomes.

In Short

• Provide medical/clinical guidance for complaint investigations.
• Evaluate information from clinical specialists and hospital staff.
• Train complaint staff on medical conditions and internal procedures.
• Perform complaint trending analyses and participate in quality reviews.
• Analyze aggregate complaint data for regulatory submissions.
• Communicate relevant clinical information to internal teams.
• Support process improvement projects as needed.
• Work collaboratively with cross-functional teams.
• Adhere to company health and safety protocols.
• Represent leadership in quality compliance projects.

Requirements

• Bachelor's Degree or Equivalent in a related field.
• Eight years of experience in the Medical Device Industry or clinical environment.
• Experience in a large manufacturing company is preferred.
• Strong project management and presentation skills.
• Proficient in Microsoft Office Suite, especially Excel.
• Knowledge of FDA’s Quality System Regulation and Medical Device regulations.
• Excellent documentation and communication skills.
• Ability to manage competing priorities effectively.
• Attention to detail and professional interaction skills.
• COVID-19 vaccination required for patient-facing roles.

Benefits

• Competitive salaries and performance-based incentives.
• Wide variety of benefits programs for employees and families.
• Supportive work environment focused on patient care.
• Opportunities for professional development and growth.
• Collaborative culture with leading clinicians and researchers.