SUMMARY OF POSITION:
Responsible for the overall management of customer complaints and CAPA’s for the corporation. Develop, analyze and publish divisional and corporate quality metrics. Function as both the corporate and divisional resource in conducting field complaint investigations. Provide quality engineering expertise (including investigations, CAPAs and training) to support both corporate and divisional activities. Evaluate and recommend process/procedure improvements as necessary and assure they are effective. Track, trend, and act on CAPA program requirements in a systematic and effective way to their closure. Promote accurate and consistent investigation practices across all levels within the organization. Review and evaluate potentially sensitive and confidential business information and develop recommendations to divisional and corporate management. Ensure compliance with FDA, Canadian and European Regulations of CAPAs and complaint handling.
- Develop and maintain corporate systems for the control and management of customer complaints and internal Corrective and Preventive Actions.
- Lead the effective deployment of the corporate CAPA system and provide Engineering support for Complaint and CAPA processes
- Facilitate cross functional activities within Production, Quality, Engineering, Sourcing, and other personnel to complete investigations. Work effectively with other departments (such as Quality, Manufacturing, Sourcing, Engineering, etc.) to support complaint investigations including determining root cause(s).
- Thoroughly investigate, document, process and maintain complaints and CAPAs in a uniform and timely manner and act as an unbiased investigator with questions surrounding the specific issue.
- Escalate issues to CAPAs if appropriate. Work effectively with complaint related CAPA Process Owners to determine root cause(s), formulate and document suitable corrective and preventive actions, and determine appropriate effectiveness checks.
- Evaluate corrective actions in regards to trends. Proactively generate reports and metrics to keep management abreast of emerging domestic and international complaint trends. Monitor, analyze, and trend complaints and RMAs and submit for Quality and Management Review processes on a periodic basis.
- Perform follow-up activities to coordinate the completion of complaints and CAPAs and perform implementation and effectiveness checks for investigations as needed.
- Identify and implement preventive actions to eliminate the potential for non-conformities to occur.
- Support with MDR, EU Vigilance and other international complaint documentation.
- Revise Quality System documents as instructed to ensure compliance with applicable regulations.
- Maintain customer complaints and communicate effectively with customers as required
- Provides relevant notifications to functional areas regarding CAPA implementations and its closure status
- Development and modification of Risk management files
- Participate in audits and inspections, including FDA Notified Bodies and Customer
- Continuous analysis and improvement of protocols, systems and processes ensuring internal and external regulatory requirements are met
EXPERIENCE, EDUCATION and SKILLS:
BS degree in a scientific discipline or equivalent experience
Working knowledge of cGMP and CFR requirements and regulations
Working knowledge of ISO and FDA requirements.
Excellent reading, writing and verbal skills with the ability to influence and motivate other team members
Strong organizational skills and ability to ascertain priorities for diversified tasks.
Ability to work independently with little supervision using good problem-solving skills.
Ability to handle multiple tasks in a changing environment.
Computer literacy and proficiency with strong MS Suite (Word, Excel, Access, Outlook) a must; Visual Manufacturing software knowledge desired.
Remain current in regulatory expectations and industry practices regarding complaint management and CAPA