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Sr Product Complaint Analyst

3 months ago

Arden Hills, Minnesota, United States Boston Scientific Full time

Recruiter: Spencer Gregory Hale

Sr Product Complaint Analyst

About the role:

Provides technical, reporting, and analytical support expertise in reviewing of product quality complaints, serving as primary contact. Monitors complaint information and provides technical expertise to optimize complaint analysis strategies and systems. Monitors systems and data to facilitate the appropriate and timely handling of all product complaints per the company's compliant handling procedure. Ensures compliance with applicable regulations, company policies and procedures.

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

Requisition ID:587335

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 a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.



Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran