QUALITY ENGINEERING PROFESSIONAL
Proven Quality Engineer with 13+ years of progressive experience in developing, maintaining and improving quality systems. Committed to collaborating with all levels of an organization to assure suitable systems and the distribution of safe and effective devices.
SELECTED AREAS OF EXPERTISE
* ISO/MDD/FDA Quality Systems
* IQ/OQ/PQ
* Statistical Analysis (DOE, MSA, ANOVA)
* Corrective & Preventive Action (CAPA)
* Inspection & Test Methods (GD&T)
* Supplier Development & Control
* ERP Implementation & Optimization
* 5S/Lean/Six Sigma Tools
Strong work ethic, attention to detail, and dedication to personal development along with team orientation underscore ability to solve problems and achieve objectives.
SELECTED ACHIEVEMENTS AND BUSINESS CONTRIBUTIONS
* Key member of a group created to establish an ISO 13485 quality management system for an early stage medical device company developing an implantable cardioverter defibrillator. Planned and co-authored quality system with Director of QA. Participated in audits and findings resolution. Certification obtained within project schedule.
* Spearheaded work to determine if specifications could be relaxed on a component with high reject rates. Designed an experiment (DOE) that investigated the effect that out-of-tolerance conditions and their interactions had on fatigue failures. Presented results to technical stakeholders and formalized into an engineering test report that justified the loosening of design specifications. Reject rates improved from 23% to 0%.
* Focused a team assigned to develop a dip coating process. Created a process development tool to align design specifications to processing parameters. Promoted the use of statistical tools and techniques to identify key input variables and assure process outputs including the use of suitable measurement methods.
* Collaborated with critical component manufacturer to resolve shipment delays due to rejects at final inspection. Designed and conducted GRR study to quantify and analyze variation. Determined operating definition, gauge configuration and resolution were inadequate as evidenced by excessive variation due to both repeatability and reproducibility. Refined operational definition, procured suitable equipment, and increased resolution. GRR improved from 56% to 6.3% and from 1 distinct category to 10 allowing the use of variable control charts and process capability indices.
* Improved capacity and on-time shipping status for multiple facilities. Planned and implemented activities for transferring FDA regulated production to a new facility. Consolidated multi-site systems into one corporate quality system. Audited the facility. Brought organizations into compliance and registered with the FDA. Hired and trained assembly personnel.
* Led a cross-functional team based in two facilities that developed and executed a plan to improve inter-company communications and operations. Team consolidated MRP, accounting, and document control into one corporate ERP system in 3 months within budget.
* Re-engineered repairs process that improved repair turnaround time 60% and required one fewer f/t employee. Identified non-value-added activities. Sorted work area. Set tools in order for new cell layout. Transferred documentation from hard copy to electronic ERP system. Documented process. Trained technicians.
* Quality lead on a team that implemented Lean methods in the assembly of medical devices. Learned and implemented 5S and one-piece flow cellular manufacturing. Designed assembly layout. Created and began a red tag and shine program. Developed and delivered “Lean 101” training to employees.
PROFESSIONAL EXPERIENCE
InnerPulse, Inc., Durham, NC 2006 – Present
Sr. Quality Assurance Engineer (2009 – Present)
• Quality lead for development of manufacturing processes and supporting device master record documents for class III medical device. Defined documentation content, format, and inspection criteria for laser welding, soldering, cleaning, molding, and coating processes.
• Provided operational and quality expertise for development and implementation of ERP system.
• Collaborated with Product Development to identify and define product requirements and specifications.
• Completed design verification activities including supplier development and process readiness to protocol generation, test execution, corrective actions, and report approvals.
• Managed and developed receiving inspection, equipment control, and document control personnel.
Quality Assurance Engineer (2006 – 2009)
• Promoted and provided statistical analysis expertise to product development and manufacturing engineering.
• Established receiving inspection function including identification, procurement, installation and qualification of equipment and measurement systems.
• Developed equipment installation, qualification and process validation process and supporting procedures and templates.
Quality Consultant to Pro-Dex, Inc., Durham, NC 2006
• Conducted a PFMEA for assembly process of a medical device.
• Performed on-site quality system audits.
Pro-Dex, Inc. 2003 – 2006
Quality Systems Manager, Beaverton, OR (2005 – 2006)
• Managed day-to-day manufacturing and quality operations.
• Established and developed relationships with key suppliers for new products.
• Supervised 9 people including 8 manufacturing and 1 quality staff.
Quality Systems Manager, Santa Ana, CA (2003 – 2005)
• Served as liaison for all external audits (i.e., UL, CSA, OSHA, FD...
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