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Manager, Complaint Handling

Company Name: Hycor Biomedical
Location: Garden Grove, CA
Job Type: Full Time
Contact Name: Go to ADP webpage

Job Description

  • You will have overall responsibility for day-to-day complaint processing at multiple company locations in the US and EU.
  • Perform reportability determinations in conjunction with medical advisor as necessary.
  • Lead Complaint Handling Unit and cross functional team of individuals through completion of investigation and closure of reportable and non-reportable product complaints in accordance with established company procedures and worldwide regulations and standards.
  • The role requires approval of complaint investigations, escalation of trends and product problems, and awareness of new or revised regulations and/or guidelines.
  • The Manager will drive continuous improvement through corrective and preventive action processes, lead continuous improvement activities, and provide subject matter expertise on complaint handling requirements.
  • Reviews and continuously leads efforts to improve the global complaint handling and post market surveillance processes.
  • Maintains and continuously improves highly effective procedures in complaint processing and complaint investigation.
  • Drives harmonization across the company.
  • Maintains dashboards and other reports of performance metrics.
  • Measures key performance indicators to assess the health of the complaint investigation process.
  • Authors and approves customer response letters.
  • Reviews and approves investigations completed by team, including investigations related to reportable complaints.
  • Drafts response communications to inquiries from regulators.
  • Supports internal and external audits (e.g. FDA) of complaint handling function.
  • Serve as a subject matter expert (SME) for complaint processing, complaint investigation and MDR reporting during audits and inspections.
  • Maintains compliance to applicable foreign and domestic regulations governing the management and processing of medical device related complaints including Protected Health Information (PHI) and patient privacy laws.
  • Provides management direction, motivation, and support for personnel.
  • Provides leadership to complaint handling staff to ensure complaint files are processed in a uniform and timely manner.
  • Ensures that each staff member has clearly established goals and objectives, monitors staff performance, conducts periodic performance evaluations and compensation planning, and ensures succession planning for key positions, including own.
  • Develops, coordinates, and otherwise ensures appropriate training for associates.

Job Requirements

  • A Bachelor's degree in Science, Engineering, Nursing, Biology, Chemistry or related technical field or equivalent experience is required
  • 8+ years of related experience, including significant experience working in in vitro diagnostics, medical device or another highly regulated industry.
  • 2+ years of experience leading people and running projects is required.
  • Shown leadership in managing and growing staff is required.
  • Advanced critical thinking and investigation skills. 


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