Senior Product Complaint Analyst

Boston Scientific • Arden Hills, MN

1d • $69,500 - $132,000 • Hybrid

About The Position

Works in a fast-paced environment to analyze customer complaints for the Electrophysiology Complaint Management Center (CMC) to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. Responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Communicates event investigation results via regulatory reports and written communications, as appropriate.
At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.

Requirements

• Bachelor’s degree, or an equivalent combination of education and experience in lieu of a degree
• Minimum of 5 years of experience in medical device complaint processing and reporting

Nice To Haves

• College Degree focus in Biology, Health Sciences, Biotechnology or Engineering preferred
• Self‑motivated, goal‑driven, and results‑oriented team player
• Strong written and verbal communication skills
• Excellent time management and organizational abilities
• Experience with SAS, PowerBI, or TrackWise applications
• Experience reviewing scientific literature

Responsibilities

• Applying 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.
• 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.
• Participate in onboarding, training, and continuous improvement initiatives.
• Provide constructive guidance and coaching to new or less experienced analysts, providing actionable feedback that supports skill development and builds confidence.
• Solves a range of problems of varying scope and complexity, generally applying existing solutions, while exercising autonomy or applying judgment based on experience to develop new solutions.
• Lead & create team engagement around continuous improvement goals for safety, quality, service, cost and space through the utilization of lean and operational excellence tools and best practices.
• Regularly participates in discussions and presentations in small meetings, logically presenting information to convey key messages.
• May lead small projects or project steps with manageable risks and resource requirements.

What This Job Offers

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