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Online Resumes with "Supplier Audits"
BSI ISO 13485:2003 Lead Auditor (TPECS) Certification - Certificate: 7930649-76913 * Hired and entrusted by B Braun McGaw of Puerto Rico and LeMaitre Vascular to implement a wide-array of corrective actions and systems resulting from 3 FDA warning letters. Subsequently after new systems implementation received 0 FDA 483 observations for a combined period of 12 years. * Built company-wide shared quality visions which complet...
Tags for this Online Resume: Documentation, Quality Assurance, Compliance, Pharmaceutical Industry, Quality, Quality Control, Regulatory Affairs, Medical Devices, Pharmaceuticals, Regulatory Compliance
SKILLS SUMMARY * Supplier Audits * Regulatory Compliance * Issue Resolution * Training * Vendor Sourcing * Co-packer Management * Product Development * Quality Systems * Specification Development
Summary Twenty-two years in the Medical Device Manufacturing Field, including 16 years of Director level experience in Quality Managements Systems, Regulatory Affairs and Quality Assurance/Quality Control Activities. Knowledge and professional experience in the following areas: Quality, Engineering and Manufacturing Implemented practical oversight of the following: * ISO13485 * ISO9001 * 21CFR820 (FDA) * ISO14971 Risk Manag...
Tags for this Online Resume: Audit, Engineering, Management, Management Review, Manufacturing, Medical, Quality, Quality Assurance, Quality Control, Regulatory Affairs, steel, medical device, medical devices, Quality Director, Director of Quality & Regulatory
SUMMARY Highly creative and driven Procurement professional with over 15-years' experience of executing best in class purchasing practices, management of complex subcontracts, lean implementation and new product introductions (NPI) that exceed organizational requirements. These accomplishments were achieved by partnering and collaborating with cross-functional teams, internal clients and suppliers, to effectively manage my ...
SUMMARY OF QUALIFICATIONS More than 20 years experience as a Mechanical Engineer, with an extensive background in Project Management, Product Design and Product Development. Coordination of manufacturing both in the US and Asia with hands on management of tooling, tool development, injection molding, machine work and all levels of assembly and production. Developed manufacturing processes and audit standards for Asian facto...
Sr. Quality Engineer with a comprehensive knowledge of Quality Engineering and Quality System Management to support various programs including Space Shuttle Main Engine, Space Station and J-2X Upper Stage Engine for NASA. Skilled at generating, implementing, analyzing and forming Quality Engineering documents, systems and practices which meet company quality and regulatory requirements. Provides engineering support in the d...
Supplier Quality Management, ISO 13485 and supplier audits
Tags for this Online Resume: Supplier Quality Management, Certified Lean Leader, Certified Quality Engineer, Certified Master Black Belt, Certified Supplier Auditor, Certified Process Validation Expert
If your organization has a strong commitment to quality and has integrity, it would be my pleasure to be considered for employment. I am a creative problem solver with a plethora of diverse skills, talents, and experience.
Tags for this Online Resume: quality, communication, project oriented, multi task, bilingual, Audit, Document Control, Management, Quality Assurance, medical devices, Lead auditor, Manager, compliance, pharmaceutical, sap, gcp, regulatory, validation, GxP
To benefit an organization that can use a knowledgeable Six-Sigma Black Belt Quality Manager with a proven ability to continuously improve processes/customer satisfaction and supplier development while building a strong project team, and strengthen customer relation using various Six-Sigma/Project Management tools and methodologies. Responsibilities: ISO 13485, 14971 Managing/Directing quality staff. Supervising/ Mentoring ...
Career Summary My current job is Verification & Validation (V&V) Manager for UNICO Engineering for the California High-Speed Rail project. I am responsible for the requirement database, V&V status reporting, and requirements traceability and management for California Rail Builders. I also possess considerable experience with ISO 13485-QMS for medical devices standard and ISO 1497-medical device risk management. My backgroun...
Career Summary My current job is Verification & Validation (V&V) Manager for the California High-Speed Rail project. I am responsible for managing the requirements database, V&V status reporting, and requirements traceability for the California Rail Builders. I possess considerable experience with ISO 13485 Quality Management System for medical devices standard and ISO 14971:2012 Medical Device Risk Management. My backgroun...
Accomplishments illustrate extensive background in project management, team facilitation, and supplier quality systems. Skilled in enhancing supplier performance through on-site auditing process. AREAS OF EXPERTISE * AIAG, PPAP's (Control Plans, ISIR, Process Flow, Capability Studies, MSA and PSW) * * * PFMEA's Design Reviews Gaging Gaging, Calibration, Repair * * * APQP GR & R's/MSA's Preventative Action * * * * * Process ...