Dedicated and accomplished Quality Management professional with an extensive track record spanning more than two decades in orchestrating and optimizing Quality Management Systems (QMS). Adept at planning, organizing, directing, controlling, and evaluating operations within the Quality Assurance domain. Committed to ensuring compliance with international standards, enhancing operational efficiency, and driving continual improvement.Licenses & Certifications• Certified Quality Engineer (36 hrs Training)• Certified Quality Auditor (12 hrs Training) • Certified Lean Six Sigma Black Belt (33 hrs Training)• ISO 9001 Mastering QMS• ISO 13485• ISO 14971 Medical Device Risk Management• ISO 13485 IQ, OQ, PQ, Process Validation for Medical Devices• Practical Regulatory Affairs 2020-US FDA Medical Devices• Medical Device Regulation (MDR)• ISO 22000• OHSAS 18001 Health and Safety Auditor Course• ISO 14001• ISO 31000 Enterprise Risk Management • ISO 19011 Management System Auditor• QS 9000/TS16949• Logistics for Management• Project Management PMP/PMI• Kaizen Practitioner Masterclass for Quality Management • Certified Lean Management & Manufacturing in Lean Six Sigma• Business Fundamentals Marketing Strategy• VP and Directors of Product Management • MBA in a Box, Business Lessons from a CEOAccomplishments:• Implement a QMS to ensure requirements are met for: - FDA (Food and Drug Administration) FDA-483CAPA- Health Canada• FDA - UDI compliance (GUDID).• Directed company's QMS for the ISO international standard transition.• Reduced cost of poor quality by more than 78% in less than one year.Skills:• Demonstrated experience working with contract manufacturers, suppliers, or distributors. • Excellent communication skills. • Experience in quality management systems, quality system audits and KPIs. • Demonstrates passion and consumer responsibility. • Strategic, methodical, logical and detail-oriented.• Multitalented and able to perform different roles. • Good supervisory, management and networking capabilities.• Auditing, report writing, PPAP, APQP, FMEA, SPC, international quality standards, quality management systems and various ISO courses.• Perform quality assessments• Employ, and sustain quality standards• Consult with department managers• Communicate with internal and external clients• Train employees on quality measures and company policies/objectives• Coordinate and direct the implementation of new standards into practice