Quality Assurance Engineer
Resume:
Stephen Keith Ryle
***** ***** ***** ****, ******, Indiana 47001
Phone: 812-***-****
e-mail:************@*****.***
Summary: A Quality Assurance and Systems professional experienced in manufacturing, quality, documentation,
validation, qualifications, QMS auditing, customer relations, CAPA and internal nonconformance. Proven leadership skills
with the ability to communicate effectively and work extremely well with others. Broad experience in developing,
evaluating and implementing quality assurance and control systems for products and services that meet compliances
according to AGMA Standards, FDA 21 CFR, Part 820 QSR 2009, ISO 9001:2008, ISO13485:2003, United Nations CFR
49 Dangerous Goods/Hazard Materials, IEC 60601, UL and GHTF Guidance. Possess a very good understanding the
importance of compliance with respect to device safety and efficacy, ramification of non-compliance, general safety rules,
manufacturing procedures, company policies and applicable procedures.
Professional Experience:
Contract Medical Engineer
Cincinnati-Sub Zero, Cincinnati, Ohio, September, 2013 – Present
- Assures that products designed and manufactured meet customer requirements.
- Create, develop and directs design verification, plan test scripts/protocols for execution.
- Provides engineering support for design verification.
- Experience with problem-solving and risk and health hazard analysis assessment / mitigation of new product design.
Contract Quality Engineer - FDA Remediation Project
Hill-Rom, Batesville, Indiana, February, 2013 – August, 2013
- Designed, launched and Implemented change for Nonconformance and MRB Management including Continuous
Improvement Methodologies for FDA Remediation and acceptance.
Quality Assurance Engineer
Xtek, Inc. (ESOP), Cincinnati, Ohio, 2011 – 2013
- Quality Engineer assigned to OEM products and communicating quality issues and resolve with those customers.
- Facilitate CAPA and investigation of Root cause(s) concerning OEM products.
- Responsible for conducting supplier and internal Quality Management System audits.
- Author and implemented procedures, work instructions and forms for various departments throughout operations.
- Directs validation of equipment, measuring systems and processes.
- Involvement in OEM mining gears and shaft product launches (Design Review) and continuous improvement activities.
Quality Assurance Engineer
Priority Plastics, Incorporated, Portland, Indiana, 2009 - 2011
- Responsible for conducting internal audits and conducts the training of other internal auditors.
- Performs as a quality liaison between suppliers and customers.
- CAPA / NC Coordinator for the facility.
- Directs validation of equipment, measuring systems and processes.
- Involvement in IBM, EBM product launches and continuous improvement activities.
Quality Assurance Engineer
Anspach Effort, Palm Beach Gardens, Florida, 2007 - 2008.
- Corrective and Preventive Action (CAPA) Program Administrator for Orthopedic and Neurosurgical devices, Class II, III.
- Coordinated failure/exception investigations and root cause analysis.
- Trending and utilization of CAPA data in identifying existing and potential causes of product and systemic failure.
- Supported Material Review Board as the Quality representative in review and disposition of non-conforming product.
- Quality representative for Change Review Board (Design, Processes, Documentation, etc.).
- Planned and executed internal Quality Management Systems audits.
1.
Stephen Keith Ryle
18946 Union Ridge Road, Aurora, Indiana 47001
Phone: 812-***-****
e-mail:************@*****.***
Professional Experience Continued:
Quality Assurance Engineer
3i Implant Innovations, Inc., Dental Implant, Class I, II, Palm Beach Gardens, Florida, 2003 - 2006.
- Responsible for direct Quality Assurance support in Regulatory Affairs conducting failure investigations, identifying,
trending and resolving root causes resulting from internal and external customer complaints.
- Implemented Corrective and Preventive Actions regarding the failure analysis of nonconforming products /processes
and auditing the effectiveness of CAPA actions.
- Resolving technical departmental discrepancies with implementation of 6-Sigma (DMAIC) solutions for reduction in
production cycle times, overall manufacturing costs and process improvements.
- Participated as Material Review Board QA Team Member concerning non-conforming product and field corrections.
- Conducted and implemented process and measurement control for variable and attribute data.
- Performed internal Quality System audits.
Contract Quality Assurance Process Improvement Technician
External and Internal Fixation Orthopedic Medical Devices, Class II and III medical devices.
Aerotek/Synthes, Monument, Colorado, 2000 - 2003.
- Conducted and analyzed Process/Product Performance Capabilities.
- Performed and analyzed variable/attribute measurement R&R capabilities.
- Supported engineering in writing and performing IQ, OQ, and PQ protocol.
United States Army / Honorably Discharged E-4, Specialist
82nd Airborne Division, Fort Bragg, North Carolina, 4th Mechanized Infantry, Ft. Carson, Colorado.
QA Software Experience:
Agile, J.D Edwards, Infinity, Gage Tracker, Stat-Graphics, Microsoft Applications, CaWeb (CAPA), SAP, Minitab, Info-Med,
TIP-QA.
Education, Certificates and Professional Associations:
O&A Certificate of Completion; Internal Auditor of Quality Systems, ISO9001:2008, Dayton, Ohio.
AAMI Certificate of Completion; CAPA Requirements and Industry Practice, Phoenix, Arizona.
Path Wise Certificate of Completion; Analytical Problem Solving, Phoenix, Arizona.
TEN-E, United Nations CFR 49, Dangerous Good Certificate of Completion, Newport, Minneapolis, Minnesota.
Green Belt Certification, Launsby Consulting, West Palm Beach, Florida.
URS Certificate of Completion; Internal Auditor of Quality Systems, ISO9001:1994 & ISO19011, WPB, Florida.
A.P.I Certificate of NDT; Electrostatic, Electromagnetic, Ultrasonic Gage/Magnetic Particle Testing, Colorado..
A.A.S. Degree in Business Management; Pikes Peak Community College, Colorado Springs, Colorado.
American Society for Quality member since 2001.
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