Description
Summary of Qualifications Dedicated and solutions oriented professional with 14 years of medical device background mainly in Quality & Compliance * Highly motivated with demonstrated ability to set appropriate and effective priorities and implement decisions to achieve both immediate and long-term goals while managing multiple tasks and completing priorities. * Effective communication and inter-personal skills with all levels of staff and executive management. * Responsibilities have included project management, CAPA investigations, quality and compliance, internal auditing of the quality system utilizing ISO 13485 and the QSR, Council Directive 93/42/EC, corporate auditing in the US and abroad, leading the internal audit program, developing new Audit KPI, and managing the nonconformance system. * Conducting successful QSIT audits which resulted in zero 483s from subsequent FDA Investigations * Developed a successful front room and backroom operation in preparation for FDA Investigations and Notified Body Audits. * Managed the front room and back room during external audits such as notified body audits and FDA Investigations. * Prepared 483 responses and implementation of corrective action * Developed a Risk Based Auditing System to better use the company's resources. * Posess effective procedure writing skills (Quality Manuals, SOP, Work Instructions) and Training Programs. * Effective communication skills to influence a professional audience through formal presentation or written report. * Ability to prioritize and complete projects within agreed timelines, excellent analytical skills, and ability to evaluate data and draw conclusions. * Ability to adapt easily to new concepts, shifting priorities and responsibilities * Support newly acquired companies in developing their quality systems * Integrating acquired company's quality systems in to the Teleflex quality system. * Document Control
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