Description
PROFILE Quality Management professional with experience in Quality Engineering and Regulatory Compliance for Pharmaceutical, Medical Device, Automotive, and Aerospace products industry. Strengths include combining technical writing skills with business expertise to streamline processes while complying with domestic and international requirements. Results-oriented, consistently delivering high quality outcomes and recognized for ability to develop strong and productive partnerships with customers. Developed, implemented, and successfully achieved ISO-9001-2015, ISO-13485, ISO-9001-2015/AS9100, and TS-16949, certification from BSI and InterTek Systems. Certified RAB ISO-9001 Consultant, Lead Auditor, Six Sigma certified. Selected Achievements: * Implemented and maintained quality system strategies, procedures, and activities including defining quality objectives and performance metrics, training, auditing, and corrective actions to ensure conformity to standards while delivering to the business bottom line. * Led and achieved ISO certifications ISO 9001-2015 and 13485 based assessments for Medical Device Directive Compliance by European Notified Bodies often changing scope of registration to accommodate business needs.
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