Boston Scientific Sr Product Complaint Analyst 

United States, Minnesota, Arden Hills 

363434445

Spencer Gregory Hale

Your responsibilities include:

• Analyze complaint data for all internal and external customers.
• Interact with the product analysts, engineers and unit managers regarding complaint analysis.
• Completes MDR/MDV assessments for all assigned products
• Accountable for managing thorough and accurate complaint records, as well as timely closure of complaint files
• Ensure complaint records, Regulatory reports, and applicable complaint handling documents are compliant with Good Documentation Practices (GDP)
• Complete mandatory training by established due dates
• Maintain accurate and current training records at all times
• Partner with Complaint Investigation Sites (CIS) to ensure thorough and timely investigation reports for returned product.
• Professional contact with customers to gain insight into each complaint event
• Prepare and submit Regulatory reports within the mandated timelines
• Review and approve assessments/reassessments/MDR/MDVs as required

What we’re looking for:

Minimal requirements:

• Bachelor’s degree
• 3+ years of experience handling product quality complaints in med device OR 5+ years of general product quality complaint handling
• Strong proficiency in common computer applications such as Microsoft Office (Excel, Word, and Outlook)

Preferred qualifications:

• Excellent written and verbal communication skills are essential
• Must be self-motivated, goal-driven and results-oriented team player
• Critical thinking and good time management skills
• College Degree focus in Biology, Health Sciences, Biotechnology or Engineering preferred
• Hands-on experience in medical device complaint handling

Among other requirements, Boston Scientific maintains specificprohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to aprohibited substancetest as a requirement. The goal of theprohibited substancetesting is to increase workplace safety in compliance with the applicable law.