I am a highly dedicated, solutions-oriented individual eager to obtain an active, challenging position where I can apply my Quality Management experience to make significant bottom-line contributions in a performance-critical environment. I also have the ability to coordinate and manage concurrent projects while focusing on the overall scope. Excellent interpersonal and communication skills; keen focus on excellence in job performance and teamwork to obtain optimal results.
CORE COMPETENCIES:
• Non-wovens (CE credits)
• Polymer Science
• High Performance Team – facilitator
• Lean Principles (GB certified)
• Statistics (Minitab)
• Bioprocess Engineering
• Heat and Mass Transfer
• Process and Control Dynamics
• Kinetics and Reaction Engineering
EDUCATION
• Bachelor of Science in Chemical Engineering, New Mexico State University at Las Cruces
• Continuing Education (CE) – Nonwovens Course, North Carolina State University
• ASQ CQE Certified
• ASQ CQA Certified
• ASQ CBA (scheduled October 2015)
• ASQ CQM/OE (scheduled March 2016)
• RABQSA Trained (ISO 13485: 2003)
PROFESSIONAL EXPERIENCE
Ethicon October 2014 to present
Quality Operations Manager, San Angelo, TX
• Ensures compliance to 21 CFR Part 820, Part 4, Part 210 and Part 211
• Responsible for all process flow from incoming raw materials through all processes including packaging and sterilization
• Have 9 direct exempt reports
• Supported customer complaint system for Ethicon site. CAPAs are to be provided for chronic issues. Root Cause Analysis has to be provided followed by effectiveness of the CAPA.
• Team responsibilities:
o answering for CAPAs, non-conformances and audit observations
o New Product Introduction
o Process Optimization
o Supplier relationships
• Conduct internal audits
• Host internal, corporate, Certifying Bodies and FDA
Cardinal Health October 2010 to October 2014
Supervisor Quality Engineering, El Paso, TX
• Support and give direction to12 China processors through a Singapore and Shanghai team of engineers. Also support and direct quality operations for the Dominican Republic, Delicias, Mexico and Cuauhtémoc, Mexico. This includes implementation of new products to the facilities’ portfolio. We monitor processes to ensure consistent quality, while complying with regulatory requirements.
• Lead a meeting where cross-functional teams come together to address “noise in the field”. Areas such as R&D, clinicians, marketing, sales, engineering, NPD, manufacturing facilities and quality call in to the meeting. Proactively, this team makes decisions on what is coming or being heard and addressed quickly before it becomes a problem.
• Lead benchmarking events with sales, marketing NPD, R&D, engineering and quality to be understand what the market has to offer and build on it.
• Manage the Incoming Inspection department for all raw materials used in the above facilities. This includes all Pre-shipments, Skip-lot and Certified suppliers.
• Continual communication with raw material suppliers through Quality Improvement Team (QIT). A program dedicated to the process monitoring through statistical methods (i.e. EWMA charts, Cpk’s, etc…) for the raw material suppliers.
• Supported all facilities with Regulatory Information (i.e. 510K, MDL, etc…).
• Have performed internal audits, inter-facility audits as well as supplier audits.
• Participated in audits performed to our facilities from internal, corporate, FDA and BSI (both surveillance and re-certification audits).
• Manage the centralized customer complaint system for all Cardinal Health – Convertors system. This includes all facilities including the China processors. This includes all design, supplier and workmanship issues. CAPAs are to be provided for chronic issues. Root Cause Analysis has to be provided followed by effectiveness of the CAPA.
• Customer audits/visits when necessary from complaints.
• Helped in the implementation of High Performance Teams for our quality department. This helped make team...
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