R ONAL D HANSEN

** **** **** ***** • Fitchburg, MA 01420-5726 • 978-***-**** • acgdea@r.postjobfree.com

P ROF I LE

Possess the hands on experience and educational background using an analytical approach in Quality Engineer while

a lso bringing the devotion towards work with honesty, integrity and time management skills to benefit and assist in

t he further development and growth of the company.

TECHN ICAL SKILLS

• • •

Agile/Product Lifecycle Microsoft Office 3D CAD Design Software/Metrics

•

M anagement Applications Quality Improvement/Data

• •

ISO 9001 / cGMP FDA CNC Machine M apping

•

Regulations P rogramming IPC-610, IPC-620 (Columbia Tech)

• • •

FDA QSR / 13485 Quality Quality Documentation System Design and

•

Systems Systems Analysis & I mplementation

• •

Internal Auditing Experience Design SAP/ECO’s/Project

• •

Six Sigma Certificate Systems Development I mplementation

•

(Evergreen) L ife Cycle PC Configurations/Hardware

• •

CAPA/Design Quality Lean

•

Assurance Methodologies/Testing

EXPER IENCE

02/2012 – Date

Columbia Tech / Cogmedix Inc. West Boylston, MA

Quality Engineer

• Strong leadership and ability to drive compliance and cGMP results.

• Perform internal audits, and follow up on Internal Corrective/Preventive Actions and maintain audit records.

• Experience in electrical hardware and electromechanical assembly design and new product introduction

p rocess.me

• Set up and coordinate and/or facilitate improvement Material Review Board (MRB) project teams and

maintain RMA.

• Manage nonconformance and ensures the conformance to requirements of all products produced internally

and externally.

• Strong leadership and ability to drive compliance and cGMP results and support project for new product

i ntroductions (NPI)

• Review QA statistical data and prepare quality metrics reports and progress toward quality goals including,

F irst Pass Yield (FPY).

• Provide training and supervision; Develop test procedures and inspection plans for components,

subassemblies, and finished goods.

• Supports New Product Development activities in terms of process and product qualifications/validations for

I Q, OQ, PQ of equipment .

• Ensure timely resolution of supplier failure, Root cause analysis and implementation of corrective actions

and preventive actions (CAPA).

• Conduct audits, including closing out audit findings, creating audits finding reports and determine proper

corrective and preventive actions.

• Development and implementation QAF for in-process inspections procedures using best industry practices

and DMR databases and records.

• Responsible for continual improvement activities to enhance the quality system, such as 5S, Kaizen lean

methods, F MEA, Control plan, etc.

• Continuously improving QA receiving inspection process and procedures and k nowledge of ISO 9001 and ISO

13485 Quality Mgmt. Systems.

• Support the Quality Inspectors to ensure that products and processes comply with the relevant requirements

of the quality management system.

08/2008 – 07/2011

Evergreen Solar Inc. Devens, MA

Group Leader (Operation Mgr.)

• Responsible for supervising the activities of product teams or staff in a manufacturing area.

• Able to interact with multi-disciplinary teams such as production, process, quality and maintenance team

• Leads the advance product quality planning teams and monitors project status through time line management.

• Lead and guide the team for continuous improvement process and analyze to support various research projects.

• Expert in cell fabrication experience, operate complex systems and equipment in strict accordance with

current SOPs.

• Experience with running or supporting GMP manufacturing operations a nd laboratory information

m anagement system.

• Drive yield improvement projects, v alidate systems, new lab instruments, design and execute experiments to

acquire data.

• Ensure that all established safety standards are observed while work is performed, including the wearing of

safety apparel.

• Responsible for planning and implementing quality testing procedures, scheduling project plans, and

p reparing documents.

• Analyze data within the framework of statistical process control, troubleshoot equipment issues and

p rogramming, if necessary.

• Perform responsibilities of developing testing methods, writing quality testing procedures, and checking

quality to ensure compliance.

• Self-motivated team player, multitask, ability to produce results in a timely manner and functional

specifications for the processes wafers.

• Experience in product and test engineering in semiconductor assembly, conduct process characterization,

and test parameter optimization.

02/2006 – 08/2008

I ntel Corporation, Hudson, MA

M anufacturing Technician

• Collecting and evaluating operating data to conduct on-line equipment adjustment and ensure process

optimization.

• Running lots to ensure highest quality, i nstalling, moving and upgrading information systems hardware,

software and peripherals.

• Performing basic electronics of these toolsets, troubleshooting wafer defect sources, installation, and repair

operation semiconductor.

• Conducting improvement processes, troubleshooting experience on 200 or 300mm equipment and k nowledge

of process control systems.

• Strong knowledge of factory operations/strategy and semiconductor production (Thin Films, Diffusion,

P lanar, Implant, Litho, and Etch).

• Solving problems while using each situation as an opportunity for staff development, study machine

performance and recommend solution.

• Integrated-circuit fabrication experience, in multi-chamber single wafer etches /cleans processes and

equipment (Fluids, Chemicals, robotics, pneumatics, electronics, and plasma etch).

E DUCAT ION

F itchburg State University, Fitchburg MA

Bachelor of Science in Computer Information Systems

I nterest

Soccer

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