1. CHRIS SUTTON
865.202.0711 | chriskisha2003@gmail.com | Maryville, TN
1 | P a g e
Skills
Excellent Communication skills
Corrective Actions
SAP Proficient
Validation
Internal Auditor
Quality Management/Engineering
Change Control
Production Manager/Supervisor
Continuous Improvement
FMEA
Experience
Quality Engineer
Scapa Tapes North America | May 2011 – Current
Tier 1 medical device contract manufacturer for the world’s top healthcare companies
Worked in ISO 9001:2008, ISO 13485:2003, FDA registered, ANVISA (Brazil) registered, and
cGMP compliant facility
Developed training tools for QC staff to ensure relevant skill set for multiple customer
requirements
Authored multiple technical documents and SOPs including Change Controls, Engineering
Change Orders, CAPA procedures, and work instructions
Quality Engineering professional in medical device contract manufacturing company
Quality Control Supervisor of 12 person Quality Control staff and Lab personnel
Manage several cross functional CAPA investigations and reporting teams
Interacted with Customers and Suppliers to solve complex quality issues
Performed Batch Releases of Medical Devices (Domestic & International)
Ensured material traceability to conform with regulatory requirements
Quality Lead during several product launches, including FMEA activities
Quality Management representative during SAP Software Validation
Authored and executed multiple process and product validations
Facilitated in updates to Customer Quality Agreements
Performed Internal and supplier quality audits
Manufacturing
Denso Manufacturing Tennessee | Oct 2000 – May 2010
Tier 2 Manufacturer of Instrument Clusters to Top Automobile Companies
• Operator of Hydraulic and Pneumatic Machinery in Injection Molding and Printing
Departments
• Department Lead in Kaizen Activity 7 straight years (Continuous Improvement Activities)
• Executed daily Maintenance checks of machines and tools at multiple workstations
• Solder 3 Component Application & Repair Certified (including lead free solder)
• Operator of Robotics in 7 Final Assembly and Sub Assembly Lines
• Monitored Defect Trending utilizing X-bar R Charts
• Troubleshooter Technical Training Class 2
• Inspected incoming raw materials
2. CHRIS SUTTON
865.202.0711 | chriskisha2003@gmail.com | Maryville, TN
2 | P a g e
• 7 Perfect Attendance Awards
• 18 Quality Awards
Senior Technician/Site Supervisor
RLS Assembly | May 1996 – Oct 2000
Contract Assembly Service of Consumer Products to the Largest Retail Chains in East Tennessee
• Demonstrated equipment operations and work and safety procedures to new employees
and assigned employees to experienced workers for training
• Determined production standards and goals based on company policies, equipment and
labor availability and workloads
• Trained and managed 8 employees and achieved significant improvements in productivity
• Observed work to ensure that operators conformed to production and processing standards
• Established work schedules, assignments, and production plans to meet company goals
• Interpreted specifications, job orders and company policies and procedures for workers
• Recommended personnel actions such as hiring, promotions and administrative actions
• Implemented changes to improve production methods, product quality and efficiency
• Inspected materials, products and equipment to detect defects and malfunctions
• Wrote, designed and produced Job Instruction Sheets for assembly processes
• Requisitioned materials, supplies, equipment parts and repair services
• Managed project charts for reporting of production outputs
• Planned and developed new production processes
• Enforced safety and sanitation regulations
• Set up and adjusted tools and equipment
Education
Pellissippi State Technical Community College
Heritage High School
Other information and Interest
Professional photographer
Microsoft Office proficient
