Engineer Six Sigma
Resume:
PATRICK E. SCANLON, ASQ Six Sigma Black Belt,CQA
Chicago, Illinois 60647
abn21k@r.postjobfree.com
Value driven Objectives
Quality Engineering/Manufacturing position with strengths of organization, enthusiasm,
technical problem solving, communications, lean and six sigma manufacturing tools, and
delivering bottom line results with a disciplined, data driven approach. Expert in
medical device manufacturing and CFR 820, risk analysis, ISO 14971, ISOtrain, and Track
wise.
SUMMARY OF QUALIFICATIONS
Creative, Energetic, results-oriented leader with over 20 years with a proven record
in, quality, engineering and design.
Experience in Plastic, CNC, Medical, Aerospace and ISO 13485 registration. Master and
project validation experience IQ, OQ, PQ and PPQ. Developed protocols using DOE, Good
document practices and other statistical methods and PPAP submissions and APQP
planning. Complaint handling CFR 820.198. Wrote, controlled and edited Sop's and work
instructions, used agile, administered CAPA using such tools as Fishbone, Poisson
distribution and time series. Gauge R&R for process certification and other improvement
projects and problem solving. Used Quality tools for risk review.
Summary of Work Certifications
- Participating in the Master Black Belt exam writing workshop at ASQ.
- Certified Pratt & Whitney SQE-worked and managed certified AS-9100 and ISO 9001
environment.
- ASQ Certified Six Sigma Green belt and Black Belt. Quality process control plans and
regulatory compliance.
- Extensive experience in hands on manufacturing environment, Castings, polishing, LSI.
Design and quality Planning. Lean manufacturing, 21CFR 820, worked as point person with
FDA and compliance.
- Received affidavit for Black Belt project for improving on time deliverers and
reducing waste by 30%.
- Audits- first, second, and Third party. Edited quality manual, sops, work
instructions and developed control plans.
- Worked with silicon medical injection molding.
Specific skills in, Solidworks, Microsoft Excel, Minitab and GD&T.
Professional Experience
Fresenius-Kabi contract engineer Dec.2011- April 2012
-Participated in transferring Seattle office to Chicago, with in GMP requirements.
-helped set-up service center for repairs from the field and developed quality trending
reports.
-Worked on integrating Design content into whole manufacturing Process.
-Updated complaint handling system and design history files to ensure all information
was transmitted correctly.
-developed procedures for organization of warehouse.
Hospira as a consultant In the global R&D and Design control subsystem
July2011-Oct.2011
-Documentation consolidation and value added compliance, aliening CFR, Corporate policy
and site policies.
-Regulatory and product development across the product development life cycle-PDP
process.
-Change management control and harmonizing site, corporate and CFR quality regulations.
-Documenting design verification and Validation activities-reviewing lab policies and
calibration program.
-Working across departments to close the gaps from internal audits, GMP's, GLP and
DHF's- created VRB boards.
Consulting and Contract work-2007-2011. CAPA project at Stryker Medical-
820.100,820.30 and linkage to all elements in CFR820, ISO 13485 and GMP's
Quality and Mfg. Processing improvement.
Medtronic Validation engineer/CTS Corp./Hendrickson-DOE Root cause analysis
- Consulting/compliance - design and control of high volume polymer hearing protection
devices (Tasco Corp. E.Prov. R.I.).
- Provided direction for Tasco products in development of plastic and silicon injection
molded hearing attenuation products.
- Designed and detailed a new switching mechanism to meet additional regulatory
requirements.
- Recertification study, lean and Six Sigma advance studies helped ASQ develop and
write Six Sigma Green Belt exam.
- Product, Process, and Design through Quality functional Development and risk
analyses.
- Worked with customer requirements and director of engineering to evaluated silicon
materials and processes.
- Did complete assemble in solidworks of components and enclosure in 3D-and developed
improved manufacturability.
- Developed 2D prints of all components and completed assemble
- worked with suppliers and engineers for optimizing manufacturing process and reducing
risks.
Medical Quality Engineer- Contract
Accellent Mfg. April 2007-Aug. 2007 Quality Engineer-CNC and tooling environment. IQ,
OQ, PQ with inspection methods.
- Worked on development of medical product processes and launch of products within ISO
13485 & Quality System Regulation.
- Review NCMR and Capa-designed and deployed systems for complaint handling and
resolutions.
- Resolved customer corrective actions and worked with CNC department to implement
solutions.
- Wrote SOP's, work instruction and quality alerts to align work methods and
inspections with overall company quality policy.
- Worked with new product engineers to understand and validate new products and
processes.
- Participated with teams to provide and support products for Stryker Medical corp.,
Ethicon and other medical companies.
Q.A.Manager-
General Machinery & Mfg. Co.-April. 2005- April 2007 CNC Machining-Aerospace
- Developed and implemented ISO AS-9100 registered aerospace quality department-
Managed 15 people and Third party audits.
- Maintain compliance to additional quality requirements listed in contracts and
ASQR-01.Project Management/People and Technical.
- Develop, evaluate, implement and monitored quality management system point person for
FAA and source audits.
- Use of statistical methods in engineering, process certification and validation plans
and executions.
- Product and performance development for aerospace, plastic and medical industries.
- Employ Six Sigma tools DFSS, DMAIC, and SPC for measuring, improving, and monitoring
processes.
- Relentless root cause analysis, FMEA, DOE, problem solving and process improvement.
- Process certification and control plans for documentation of quality complacence and
process predictability.
- Did solid molding for product development-worked with customers to resolve problems,
conducted internal audits.
Consulting Engineer- Advanced Technologies Center/Owned Great woods March 2001-March
2004
- Designed 400 watt signal device in Solidworks 3D software developed "people sense
approach to business challenges".
- Root cause analyses, hypothesis testing and inference statistics applied to material
solutions.
- Product design, and development, manufacturing engineering and development of
inspection and testing.
- Developed assembly sequences and tolerances for precision parts.
- Developed in store retail solutions and matched voice of customer to voice of the
process.
- Budget responsibilities, inventory analysis and project time line for Great Woods
retail store.
- Hands on manufacturing, trouble shooting and improvement deployment supply chain.
Senior Product Engineer
RTC Industries - Rolling Meadows, Illinois - May 1999 to Jan.2001
- Designed, evaluated, and introduced new
approaches to fast tracking projects including risk analysis and purchasing new
packaging equipment.
- Worked with clients such as Nikon, Budweiser and toys "R" Us
to develop their products, processes and make improvements.
- Doubled our accuracy in gage reproducibility & repeatability.
- Projects start to completion -on time and under budget-product concept, packaging,
mfg. quality and shipping.
- Developed guidelines for tool tracking and completion of
tooling and fixture programs.
- Worked with purchasing department for improved polymer and vendor selection.
Senior Plastic Engineer
Dana Molded Products - Arlington Heights, Illinois -Nov.1995 to Feb.1999
- Solved customer's problems by using direct aim tooling.
- Proved out a new rapid prototyping technique.
- Duties included all mold and part quoting, this included
tool construction, comparison of offshore versus
domestic pricing, assembly fixtures, time line and proper documentation.
- Computer 3D modeling of sketch concepts, analysis of tooling
constraints and pricing.
- Development of quoting programs- including resin and color
costs.
- Extensive work troubleshooting injection-molding process with
latest diagnostic techniques.
- Investigated and developed some of the latest rapid
prototyping methods.
- Responsibility for all aspects of plastic manufacturing.
- Plastic part quoting, assembly, mold quoting and procurement.
- Management of plastic product development from conception,
tooling, molding, and assembly to completion.
- Identification, selection, development, and approval of
polymeric materials.
- Worked with product designers and manufacturing engineers in
the development of new designs and the validation of materials and
processes.
Senior Mfg./Plastic Engineer
Boston Scientific - Milford, Massachusetts -Aug. 1990 to Sept.1994
- Worked on teams for product development and quality
process improvement with in an ISO 13485 cGMP environment.
- Responsibility for the design and development of plastic
medical devices. Duties included injection mold procurement, design of
plastic parts, and administration of both the tool room and the machine
design department with in FDA and GMP guidelines.
- Developed and worked with silicon materials in extrusions, injection molding and
coating.
- Development of new and modified manufacturing processes following GMP procedures.
- Wrote SOPs and protocols and validations for new and existing products, molds and
machines.
- FMEA, regulatory and customer compliance. Technical problem solving with plastic
medical devices.
Mold maker, Tool Design and equipment set-up
Plastic Mold and Engineering E. Providence R.I. Sept.1980-April to July 1990
-Worked on shop floor as apprentice and journeyman toolmaker-Mold Polishing and
tumbling.
-Operated all tool room equipment starting with squaring-up blocks to difficult form
grinding.
-Set-up molds develop operating parameters and learned how to trouble shoot complicated
machinery.
- quoted jobs, purchased material and handled customer complaints.
-Learned manufacturing starting at very bottom and working my way up.
Education
University of Rhode Island - Kingston, Rhode Island.
B.S. in Engineering/Operations Management -Admitted into MBA program.
Special Technical Training and Seminars:
Project Management. -Accepted into MBA program.
SPC and Process certification
ASQ Certified Six Sigma Green and Black Belt
Plastic product and design
MCP, passed Microsoft's certification test in NT
Engineered Properties of Materials and Plastics
CAD/CAM
Certified by APICS in Material Requirement Planning
References available upon request.
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