SUMMARY: This position is responsible for the management of the Risk Analysis, Safety Review Board, Complaint Handling and Product Evaluation processes. This includes directing personnel and managing all activities associated with safety review board, risk assessment, complaint handling, and the evaluation of returned product resulting from customer complaints. The individual shall ensure that complaints provide documented investigations that include conclusions specific to malfunction, defects or product use issues. In addition, this position will work with the Returns and Technical Services areas to identify recurring quality issues and drive corrective action. This position will also manage the process for issue escalation to Safety Review Board for assessment of risk and whether further escalation is required.

ESSENTIAL FUNCTIONS:

• Manage the Complaint Handling Unit, who is responsible for evaluation, investigation, and reportability decisions and filing for products marketed in North America
• Ensure efficient and consistent handling of complaints and FDA and Health Canada reportability decisions
• Manage and document the complaint handling and returned product evaluation process including the escalation of potential product safety related issues.
• Manage the Safety Review Board and Risk Analysis processes to ensure appropriate risk assessment and escalation determination for identified issues
• Develop and document training plans, SOPs, work instructions, technical documents that support the functional goals of the group in a compliant, efficient and consistent manner.
• Work with and engage Engineering, Supplier Quality, Plant Quality and other groups as needed to identify recurring issues and drive corrective action and improvement.
• Ensure that all required training is identified for and completed by all direct reports.
• Evaluate staffing needs and costs; identifies, hires and promotes individuals with the right skills and competencies necessary to achieve superior results.
• Participate in internal and external audits including the FDA relative to all activities, reports and files associated with the product evaluation and escalation process.
• Ensure that all required training is identified for and completed by all direct reports.
• Evaluate staffing needs and costs; identifies, hires and promotes individuals with the right skills and competencies necessary to achieve superior results.
• Develop a team environment that values diversity and uses various individual’s strengths to the benefit of the team.
• Exhibit positivity, flexibility, creativity, and a willingness to take on new responsibilities as requested or required.

Required Skills Required Experience

• Computer proficient – Microsoft Office, CRM system
• Excellent customer relations and written and verbal communication skills.
• Demonstrated track record of project management skills to deliver profitable results.
• Understanding of marketing-focused outsourced solutions.
• Excellent presentation, negotiation and communication skills targeted to C-level audience.
• Demonstrated capability of developing needs-based proposals.
• Excellent organizational and planning skills.
• Strong attention to detail and quality.
• Self-motivated with minimum supervision required.