Management Representative

Dear Mike:

I am writing to submit my candidacy for a lead quality assurance posted, or project management or sales if need be. My background with quality management systems, particularly ISO 13485 for medical devices and ISO 9001 quality systems has been successful accomplishment of the all identified tasks. My last FDA audit had zero findings. Satisfactory completion of the first year of law school and passing the CA first year bar exam for contracts and related topics makes me a prime candidate for this position. With over 13 years management-level experience and successful development of medical devices, interaction with FDA inspectors and ISO auditors, I have keen insight into compliance issues. I possess strong organizational skills and a perspicuity towards detail with the ability to manage multiple priorities and objectives.

Through audit and evaluation, I take a proactive management style with preventive actions to avert and resolve potential issues before they become problems.

As management representative for FDA inspections and Notified Body audits, I am focused on risk management and quality initiatives for improvement and cost reduction. In addition, I chair management review meetings, lead the CAPA and MRB teams, and oversee all aspects of quality related to ISO and regulatory compliance. I have experience and a working knowledge of FDA and EU Medical Device Regulations. I am a certified ISO 9001 lead auditor: certificate number L100215. Experience includes direct interaction with Notified Bodies and Competent Authorities both in a team-based or matrix work environment. I possess strong interpersonal, written and oral, communication and organizational skills; and have a working knowledge of personal computer systems and desktop office applications. I have also validated class 100 clean room facilities and equipment, and achieved validation for same inclusive of gamma and EtO sterilization efforts for product and packaging.

Some accomplishments include successful implementation for ISO certification for three sites

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