Position Title
Manager, Complaint Mangement
SBU
Corporate
Department
Quality Assurance
Relocation Covered
YES
Educational Requirements
Bachelor's degree
Experience Requirements
Responsible for supervising all aspects of complaint handling within Teleflex Medical group companies, including: customer satisfaction; documentation; database management; investigation; trend analysis; follow-up; corrective action; adverse event reporting; and recall administration Manage complaint handling transition from other Teleflex Medical locations. Establish and implement compliance training programs.
Qualification Requirements
Strong regulatory and quality systems knowledge. Supervisory / management skills. Customer service / complaint handling and problem solving skills. Computer literate (word processing, spreadsheets, databases). Documentation skills, negotiating skills and the ability to communicate effectively. Research, logic and technical writing skills. Presentation / training skills. Reasoning ability, support and prioritize projects, adapt to shifting priorities, work with minimal supervision, able to resolve problems / conflicts.
Preferred Qualifications
B.S. degree in life science, public health, allied health with 5-7 years of relevant experience; Broad regulatory knowledge base includiComplaiManagerng global requirements for: complaint handling; adverse event reports; recalls; change assessment; marketing approvals and quality systems. Experience working with FDA at the center (premarket) and district (inspections).
Responsibilities
Oversee daily functions of the Complaint Management team and investigation of Teleflex Medical distributed product, both in US and Rest of World (ROW), to resolve the immediate customer problem, identify the root cause, establish corrective action to prevent problem recurrence, and evaluate the effectiveness of corrective and preventive actions. Develop and maintain a centralized complaint database for the Teleflex Medical for complaint administration. Coordinate medical device reports for Teleflex Medical. Analyze complaint trends, provide appropriate management personnel with details in order to take appropriate action in response to adverse trends, and compile regular reports for management review. Coordinate activities with other manufacturing sites, departments and suppliers to ensure timely closure of complaints. Manage the transition of complaint handling responsibility from other Teleflex Medical locations. Stay abreast of evolving regulatory requirements in both in US and foreign markets. Ensure Complaint Specialists comply and understand compliance training programs in accordance with the annual training schedule. Other miscellaneous regulatory activities: Serve as an escort during audits, and investigations. Ensure that the company's rights are protected during FDA inspections.
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