Engineer Quality
Resume:
Lawrence D. Wolosky
Cordova, Tennessee 38018
C. 901-***-****
C. 609-***-****
SUMMARY
Self-motivated, accomplished, versatile quality professional with strong background in quality systems, computer based automatic inspection systems and manufacturing and Quality Systems. Qualified by 25+ years in Quality and manufacturing in the medical device and aerospace industries.
Areas of Experience:
Auditing
Design Control Plan
Process FMEA
Control Plans
FDA/Regulatory Affairs
Process Capability
Gage R&R
Project Management
Testing
CAPA
Metrology/Calibration
Process Test Method Validation
EXPERIENCE:
March 2020- Present Independent Consultant
Meridian Medical Technologies St. Louis, Missouri
Developed a an automatic inspection process which included the coordination of four Hexagon software products (PCDMIS, Inspect, Protect, and QDAS) into the production inspection Quality Device and Development Labs.
Creating/Evaluating/performing all Test Method Validations in this process.
Working with the internal and external organizations to create training procedures documenting these procedures and then training the operators in performing the procedures.
September 2019/ Independent Consultant
March 2020 Si02 Materials Science Auburn, Alabama
Writing and performing TMV for inspection programs, including Gage R&R and training documents.
Training inspection / manufacturing operators in the proper procedures.
Modifying existing MODUS programs on the Renishaw inspection systems.
Organizing the internal Calibration Procedures to reduce downtime and exposure to out of tolerance instruments, reducing production downtime.
November 2018/ Independent Consultant
March 2019 Viant Medical S. Plainfield NJ 02 Materials Science
Creating /modifying inspection programs using the OGP inspection system and other inspection processes.
Creating and modifying inspection fixtures and proofing the process.
Reviewing and helping to implement the Calibration system.
May 2018- October 2018 Independent Consultant
Acumed LLC
Writing and performing IQs, OQs and PQs, and PPQs for all manufacturing processes, including Lathes and mills.
Working with manufacturing personnel to understand the concepts of one piece flow.
Jan 2018 - May 2018 Independent consultant
Innovision, a Zimmer company
Writing and performing IQs, OQs and PQs, and PPQs for all manufacturing processes, including Lathes and mills and inspection equipment such as Optical Comparators
Re-writing Quality Inspection procedures and documents.
Gage R&Rs
2017- January 2018 Independent consultant
Cook Medical
Reviewing current COOK MEDICAL, LLC documents
mapping and gapping per ISO13485:2016 and FDA 21CFR Part 820 for Key Processes.
These processes specifically included
oRisk Management (ISO 3100-2009 and ISO 14971),
oSupplier Management
oValidation and Process Control
oCalibration.
Zimmer Biomet
HHE and CAPA
Assigned to provide Design Quality input to new product designs and New Product Development teams.
2015-2017 Principal Supplier Quality Engineer Medtronic Orthopedics
Managed Suppliers to create a seamless manufacturing process.
Define, review and approve Supplier Validations.
Worked closely with both Sterility suppliers and packaging departments to insure qualified product.
Issue and complete supplier SCAPAs and internal CAPAs
Provide training and guidance in performing First Time Quality initiatives.
Also, provide new product support and design review (inspection methods and capability) for the implementation the new Knee and Hip Orthopedic Division.
.
2008- 2015 Principal Design Quality Engineer Medtronic Spinal and Biologics
Recognized SME for metrology and inspection systems.
Quality representative for the Center of Excellence, developing new methods for
inspection prior to Design Transfer
Working alongside Concurrent and Product Development Engineering through NPDP, the design concept to product release following current internal standards.
Defined MSA and Validation requirements for suppliers and internal manufacturing.
Support CAPA response as needed.
Provided input into the development of Spines NPDP process and documentation.
Assisted in Risk and statistical analysis for new product releases.
Worked with teams of Product Designers and Manufacturing engineers to instruct them in Quality requirements and what is a good design that can be inspected and pass internal quality documentations.
2005 – 2008 Quality Engineer, Synthes (USA) Horseheads, NY
Responsibilities related to Medical device products as a QE including but not limited to MRB, Inspection documents, Process Validation, gaging, and all Continuous interaction between PD,ME, Regulatory /Compliance and floor personnel . Responsible for CAPA responses, new product launch, Quality responsibility for new equipment and new Process Validations.
Responsible for acquiring and implementing the Steinbichler “White Light “inspection system, using Polyworks software. Responsible for training requirements, in-house procedures, and documentation.
2002-2004 Senior Staff Manufacturing Engineer
Pratt & Whitney Aircraft Engines, East Hartford, Ct
Maintain and develop CMM inspection programs using both Tecnomatix eMPower Quality (Valisys) software and LK DMIS/CAMIO manufacturing production inspections. Responsibilities include program creation, software approval and documentation. Interface with manufacturing for production line inspection process.
1996-2002 PRINCIPAL CONSULTANT/ APPLICATION ENGINEER
Tecnomatix Techologies Inc., Northville, Michigan,
Provided onsite consultation to Pratt & Whitney Aircraft Engines, East. Hartford, CT for implementation, training, development and project management of eMPower Quality Software (CAD embedded CMM inspection programming and analysis) throughout company. Held responsibility to supervise, train and develop specialized team of Application Engineers responsible for delivery quality results to on-site customers. Accomplishments include:
Development of “Team Training” methods adopted by Pratt CPD as new process development training model for all disciplines (Quality, Mfg., and Design)
Collaborated in development of training materials and documentation for internal and external training courses.
Assisted and managed Pratt & Whitney personnel in development and incorporation of eMPower Quality (Valisys) software into their internal procedures and methodologies.
ADDITIONAL
EXPERIENCE
SENIOR QUALITY ASSURANCE ENGINEER
Howmedica, Inc. – A Division of Pfizer, Inc., Rutherford New Jersey, 1989 – 1996
Designed, developed, implemented and evaluated quality processes and procedures in compliance to GMP and ISO 9000 requirements. Various duties included maintaining inspection equipment, participating in QA teams, responding to CAPAs, installing software and writing procedures and policies associated with each.
Singer Kearfott – Materials Engineering
Installed and operated a lab injection molding press. Designed single cavity molds
for Ring Laser Gyro application.
QE SUPERVISOR/ QE Chief, ROHR INDUSTRIES
Coordinate Measuring Inspection/ Gauge Inspection, Riverside, California,
Established the CMM and Gauge Inspection Systems Department for Riverside Division.
SENIOR QUALITY ASSURANCE ENGINEER, Quality R&D Technology
Boeing Helicopter Company, Ridley Park, Pennsylvania,
Researched, evaluated, and implemented new automated and cost-effective inspection processes.
EDUCATION B.S. Manufacturing-Polymer Engineering Technology
New Jersey Institute of Technology
Many miscellaneous educational units, including those received while attending Rensselaer Polytechnic Institute towards an MS degree.
ENGINEERING
SKILLS
CAD (Unigraphics, ProE, Polyworks)
PCDMIS, Minitab, Zeiss Calypso, Polyworks, QDAS, Modus, other software
Microsoft office of Tools (Excel, Word, Project)
Vizio
ASQ Certified Auditor, Certified UTC SQA
Former ASQ Board Member- Chair, Treasurer, Secretary
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