Description

Own the end-to-end management of product complaints and quality investigations, ensuring strict compliance with global regulatory standards.

This role is on-site.

Responsibilities

• Capture, review, and analyze product complaints and customer feedback to identify performance issues.
• Initiate, coordinate, and summarize investigations for complaints, escalating safety concerns to management.
• Perform product return evaluations and interface with Field Personnel, Quality, Engineering, and Operations.
• Support audits and regulatory inspections while maintaining accurate documentation of all activities.
• Communicate directly with customers via phone and email regarding services and product experiences.

Required Skills

• Bachelor's degree in Science, Math, or Engineering.
• 4+ years of experience in a regulated cGMP environment (medical device, biologics, or pharmaceutical).
• Proficiency with Microsoft Office (Excel, Word, PowerPoint) and database software.
• Knowledge of regulations including 21CFR 820, 21CFR 803, 21CFR 210/211, ISO 13485, and EU MDR.
• Ability to read and understand technical documentation, investigations, and Service Orders.
• Strong organizational, problem-solving, and analytical skills.
• Excellent written and oral communication skills in English.

Preferred Skills

• Experience with MDD, CMDCAS, and MDSAP standards.
• Understanding of device, drug, and/or biologic operational activities.

Key Skills

Education

Bachelor's degree