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Watson Health - Quality Compliance Specialist

  • Country:US
  • State:WI
  • Category:Project Management
  • Required Education:High School Diploma/GED
  • Position Type:Professional
  • Employment Type:Full-Time
  • Contract Type:Regular
  • Req ID:141712BR
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Job Description
Title: Quality Compliance Specialist
Location: Hartland, WI (Preferred) and open to remote

Job Summary
The Quality Compliance Specialist (QCS) will be responsible for the compliance and integrity of documented complaint files and the complaint handling process. The QCS will contribute to measurable improvements in complaint handling, product safety, regulatory compliance and the customer experience. This role will work closely with a cross-functional team, including Technical Customer Support, Regulatory and Quality Assurance, Solutions Management, Engineering, R&D, Implementation/Installation, Returns, Field Service, Product Quality Assurance, and Fulfillment.

Essential Job Duties
  • Serve as a Subject Matter Expert for the Medical Device complaint handling process.
  • Drive prompt escalation and complete documentation of product safety complaints for potential FDA reporting and investigation.
  • Promptly escalate and complete documentation of regulatory non-conformances for root cause analysis and potential FDA reporting.
  • Ensure complaint documentation and records are complete and in compliance with regulatory requirements prior to closure.
  • Contribute to product safety, product quality, and/or customer satisfaction related decisions.
  • Lead/participate in complaint review board forums, conduct or assign investigations to cross-functional team members as necessary and monitor completion of tasks.
  • Escalate incomplete or overdue complaint evaluations, investigations or resolution tasks to stakeholder management
  • Participate and support internal and/or external audits and inspections.
  • Research, analyze and report on confirmed complaint trends.
  • Identify and communicate possible improvements in the work process for customers and peers.
  • Perform other duties as assigned by immediate supervisor or upper management.

Required Technical and Professional Expertise

  • Experience in technical and/or clinical knowledge of Medical Devices with Software.
  • Direct experience handling complaints in the medical industry (FDA 21CFR820, QSR compliant, and/or ISO 13485 certified organization)
  • Experience participating in internal and external Quality Management System inspections
  • Able to work as a Team Player and Individual contributor by positively influencing all levels of the organization
  • Analytical mindset, pays attention to the details and ensures accuracy
  • Ability to respond to urgent situations appropriately by prioritization.
  • Experience with Post Market Surveillance & Compliance: Complaint Screening, Evaluations, Investigations, Root Cause Analysis, MDRs, Recalls, HHEs, Risk Analysis and CAPAs
  • Ability to quickly review, analyze, summarize, and interpret complex data; draw conclusions and make appropriate recommendations and decisions
  • Adheres to GDP for documentation/objective evidence, writes complete and compliant reports.

Preferred Tech and Prof Experience

  • Able to summarize information into presentations/reports and present to cross-functional personnel
  • Quality Engineering, Medical Device Software, Networking, IT &/or Software Development Experience.
  • 5+ years in the medical industry or related field experience

Preferred Education: Bachelor's Degree Commissionable: No
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