QUALITY ENGINEER (QE)
14+-year track record of success ensuring superior levels of system, product, and service quality as well as compliance with regulations and established standards
Highly dynamic quality engineering specialist and leader with a strong background playing a key role in the operational efficiency and profitability of organizations within diverse industries, including aerospace, medical, and pharmaceutical. Reputable for establishing top-performing analytical, inspection, auditing and monitoring platforms focused on ensuring the continuous delivery of quality products / services in compliance with strict guidelines. Proficient in CA/5, LIMS, and various MS applications. Familiar with SAP and Solidworks applications.
Highlights of Expertise:
• Manufacturing
• Documentation
• Troubleshooting
• Supervision • Quality Management System (QMS)
• Continuous Improvements
• FDA, QSR, ISO, Safety Regulations
• Regulatory Compliance / Enforcement • cGMP / cGLP
• Audits
• Training
• Staff Management
PROFESSIONAL EXPERIENCE
OPEN., Boulder, Colorado
Project Manager, 05/2012 –
Support and managed quality on assigned projects, ensuring staff compliance with policies, best practices, procedures, and guidelines within IT solutions. Create procedures for audit and compliance functions.
HEI INC., Boulder, Colorado
Quality Engineer (QE), 10/2007 – 10/2011
Performed quality control operations on assigned projects / products, ensuring staff compliance with policies, best practices, procedures, and guidelines within this aerospace / ISO-FDA-regulated manufacturer. Provide support and maintenance for Quality Management System (QMS). Lead investigations, quality metrics, corrective / preventative actions, identification of raw material nonconformities, and internal / external audits.
Work with staff, contractors, and suppliers in troubleshooting problems. Liaise with production and engineering specialists to address processing issues and emphasize quality improvements. Orchestrate design control and risk management efforts in compliance with FDA, QSRs, ISO 13485, and ISO 14971 regulations. Generate quality and validation master plans as well as FMEAs and process control plans. Attend client meetings.
Key Contributions:
• Impacted operational quality with approval of engineering change orders as well as verification / validation of protocols.
• Generated improvements in quality systems, processes, and products with the introduction of new quality / engineering tools.
• Enhanced testing operations with the introduction of new methods and equipment.
AIV INC., Harmans, Maryland
Quality Assurance Specialist, 11/2004 – 9/2007
Delivered expert quality assurance to ISO-FDA-regulated medical device facility specializing in production and repair operations. Maintained CAPA (also implemented), Nonconformance, Complaint, Staff Training, and Returned Goods Authorization records. Administered quality metrics and participated in audits in addition to FDA inspections. Functioned as Internal Control Manager charged with evaluation, processing, and management of ECO. Partnered with production and engineering teams in process improvement efforts focused on product quality. Provided review / approval of protocols. Trained support team on regulatory quality system processes / tools, including cGMP requirements.
Key Contributions:
• Elevated Quality Assurance / Quality Control processes and QMS by recommending key changes and improvements.
• Served instrumental r...
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