Candidate Opportunities

Complaint Handling - 2018-032

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Lake County, IL
Job Type
Direct Hire
Nov 12, 2018
Job ID
Long standing company, known for long tenured employees; great growth potential.
Responsible for entering, processing, investigating, and closing formal product complaints in a timely and efficient manner.
  • Primary owner and responsible for compliance with Complaint Handling (21 CFR 198) and Medical Device Reporting (21 CFR 803) FDA regulations.
  • Ensure all initial and supplemental MDR reports are submitted on-time to prevent regulatory enforcement.
  • Conduct initial evaluation of products returned that are under warranty for complaint trending determination.
  • Establish and execute procedures that comply with the regulatory requirements that are suitable for company systems.
  • Manage complaint intake and evaluation for timely documentation, investigation and regulatory reporting.
  • Coordinate shipping and tracking of complaint and investigation articles.
  • Ensure timely closure of complaint files to avoid backlogs that introduce regulatory risks.
  • Maintain complaint records and logs for compliance to regulations and procedures.
  • Establish and execute complaint close-out and customer communication processes.
  • Provide monthly and as-needed complaint trends for routine and project analysis.
  • Participate in CAPA activities to identify adverse trends and measure corrective actions and effectiveness.
  • Conduct SAP transactions as required for complaint device tracking and release.
  • Provide general training to new hires on complaint handling requirements.
  • Establishing working relationships with Customer Service and Repair Operations to ensure complaint handling activities are understood and investigation data is obtained.
  • Compliance with all applicable regulatory and standards requirements for medical devices such as FDA Quality System Regulation, 21 CFR 820 and ISO 13485.
  • Aware of and comply with the corporate Quality Manual and applicable laws and regulations as they apply to this job type/position.
  • Complete all planned Quality & Compliance training within the defined deadlines.
  • BS Degree in a science field
  • 3-5 years of commensurate job experience required.
  • Must have knowledge of Good Manufacturing Practices Requirements and experience in a regulated medical manufacturing environment.
  • Must have excellent communications skills.
  • Experience with and understanding of cross-cultural differences and the ability to work within this environment is crucial for successful employment.