Product Complaint Analyst III

Boston Scientific • Arden Hills, MN

3d

About The Position

Responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Your responsibilities will include: Performs quality review and approval of records to ensure accuracy and compliance. Works independently guided by company policies, guidelines and procedures, receiving guidance on complex and unprecedented problems. Ability to apply clinical knowledge to review complaint communications and laboratory analysis to apply event coding, assess for regulatory compliance reportability, and potential impact to patient safety and business operations. Ability to participate in onboarding, training, and continuous improvement initiatives. Ability to provide constructive guidance and coaching to new or less experienced analysts, providing actionable feedback that supports skill development and builds confidence.

Requirements

• Bachelor's Degree or equivalent combination of education and experience will be considered in lieu of degree
• Minimum of 3 years of experience in medical device industry and reporting
• Self-motivated, goal-driven and results-oriented team player
• Excellent written and verbal communication skills
• Ability to apply critical thinking and sound judgment in complex situations
• Proven ability to manage time effectively and prioritize tasks to meet deadlines

Nice To Haves

• College Degree focus in Biology, Health Sciences, Biotechnology or Engineering preferred
• Experience with SAS, PowerBI, or TrackWise applications
• Experience reviewing scientific literature

Responsibilities

• Performs quality review and approval of records to ensure accuracy and compliance.
• Works independently guided by company policies, guidelines and procedures, receiving guidance on complex and unprecedented problems.
• Ability to apply clinical knowledge to review complaint communications and laboratory analysis to apply event coding, assess for regulatory compliance reportability, and potential impact to patient safety and business operations.
• Ability to participate in onboarding, training, and continuous improvement initiatives.
• Ability to provide constructive guidance and coaching to new or less experienced analysts, providing actionable feedback that supports skill development and builds confidence.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees