Global Complaints Intake Manager

Position Summary

Take ownership of the global Complaint Intake process, procedures and associated software systems. Manage regional Intake teams whose role is to enter customer-reported complaints from a variety of sources/global locations. Ensure that information is imputed in a consistent manner which provides clear concise and accurate information utilized by downstream processes such as Adverse Event Reporting, Complaint Trending and Complaint Investigations and other Post Market activities. The successful candidate will also be responsible for maximizing team performance, setting team KPIs and meeting department metrics.

Principal Responsibilities

•    Provide tactical and operational support to users of the complaint management process globally ensuring that the process is executed to Teleflex Global SOPs & Standards.
•    Use deep process knowledge and experience to assist global business partners with the creation, review, triage approval, escalation and monitoring of complaints.
•    Sustain and improve compliance of the Complaint Management Process
•    Performance management, training & development of direct reports.
•    Lead implementation of value-added improvements in collaboration with global stakeholders to achieve Teleflex strategic Quality priorities.
•    Lead and Support global Complaints teams and drive improvement and standardization globally. Collaborate closely with other sites to share best practices,
•    Identify, assess, communicate, manage, and mitigate Complaint system risks.
•    Evaluate new or revised regulations for compliance gaps and support remediation efforts for gap closure.
•    Represent complaint intake function at quality meetings, Quality Systems review Boards etc.
•    Create and update procedural documentation and work instructions with accuracy and clarity.
•    Support audits and inspections as required.
•    To actively monitor projects and to foresee/identify potential problems and proactively identify solutions to address in advance
•    Act as a trainer for the complaints Intake & Reporting team. 
•    Support the PQA Team with Ad Hoc Activities
•    Provide other departmental support as requested by the immediate supervisor.
•    Adhere to and ensure compliance of Teleflex’s Code of Conduct, all Company policies, rules, procedures and housekeeping standards.

Education / Experience Requirements

•    Bachelor’s degree or equivalent with 3-5 years’ experience in Quality Management Systems including experience in completing investigations in NCs/CAPAs.
•    Experience in Product Quality Assurance/Post Market Surveillance with experience in Complaint Handling/Vigilance Reporting – highly desirable.
•    Prior experience in the medical device industry is preferred.
•    Previous supervisory experience essential.
•    Excellent technical writing experience within a medical device environment – essential
•    Additional language skills to support regions is beneficial
•    Good working knowledge of the MDD/MDR/CFR 820/ISO 13458
 

Specialized Skills / Other Requirements

•    The ability to prioritize tasks and be able to manage several projects and tasks simultaneously and within deadlines: capable of understanding the impact of decision making on both Teleflex and their customers.
•    Critical thinking and problem-solving skills to develop creative solutions and meet objectives as required; an awareness to identify and escalate trends or issues where necessary.
•    Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, Outlook and Excel)
•    Strong report writing & verbal communication skills. 
•    Self-driven and ability to work independently and/or as a team player.
•    Approachable and enthusiastic. Flexible and adaptable.
•    Good organizational skills with cultural awareness and sensitivity
•    Strong collaboration and influencing skills at all levels – both internally and externally 
•    Goal orientated for customer and business objectives
•    Coaching/Mentoring skills
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