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Engineer Quality Assurance

Location:
Franklin Township, NJ, 08873
Salary:
135000
Posted:
March 21, 2018

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Resume:

PROFESSIONAL PROFILE

Professional with ** years of experience in Engineering, 22 of which have been in Quality and Reliability Engineering in the Healthcare industry.

Experience in medical device testing that included supplying test equipment, procedures, and training to assure consistent, reliable test results among various manufacturing plants.

ASQ Certified Quality and Reliability Engineer with experience in New Product Development Quality Assurance including Design Verification/Validation, Process Validation, and Test Method Validation.

Experience establishing a design reliability test lab to support research and development.

Well versed in the application of statistics for process optimization and data interpretation.

AREAS OF EXPERTISE

• Process Optimization

• Quality Systems

• Design of Experiments

• Design Verification

• Process Validation

• Reliability Testing

• Stability Testing

• Test Method Validation

• Statistical Analysis

• Accelerated Aging

• MiniTab – Statgraphics

• SAS for expiry dating

• DMAIC

• Alta-6 Pro – Weibull++

PROFESSIONAL EXPERIENCE

Ortho Clinical Diagnostics ( Aug 2012 – Present)

Raritan, NJ

Principal Engineer (August 2012 – Present)

Quality Assurance Operations supporting the RhoGAM Value Stream

Perform nonconformance investigations to identify root cause, scope of impact, product impact and assess product and compliance risk. Data entered into Trackwise system.

Reduced the number of Chemistry Lab OOT’s by correcting their tracking and trending spreadsheet. This significantly reduced the number of quality events.

Completed the Anti EpCAM justification to create a specification for individual raw test values. Lots were being rejected because individual values were below a specified average value.

Instrumental in the concept of making a ‘ready-to-use’ pipette assembly for Red Cells and Antisera by finding gamma stable materials and a new sterilization process. This project is on-going.

Mentored OCD Quality Engineers in preparation for taking the CQE Exam.

Assisted in setting specifications for the MTS Gel and Biovue for implementation of the new Instron Test Method for foil adhesion. This was submitted to FDA and approved.

Trained as a CCM (change control manager).

Cordis, A JOHNSON & JOHNSON Company (1996 – 2011)

Warren, NJ

Principal Quality and Reliability Engineer (May 2005 – Dec 2011)

Quality Assurance supporting New Product Development:

Automated balloon catheter testing equipment using Crescent Designs Pressure Manager software resulting in increased data collection abilities and more accurate measurements.

Designed and fabricated test equipment and fixtures to generate data that is clinically relevant. Results: In-vitro test results that better characterize Stent Delivery Systems (SDS’s).

Organize and set-up Accelerated Life Testing for determination of shelf-life as well as the degradation of drug content on CypherTM SDS’s. Familiar with FDA and ICH guidelines regarding stability of drug products. Able to program SAS.

Perform and analyze data from Designed Experiments to optimize processes. Support Integrated Design Reliability Growth program. Use Weibull++ or ALTA6-PRO to properly characterize time-to-event type data (life’s or devices). Familiar with step-stress techniques and application of cumulative damage model. Fluent in the use of Statgraphics Centurion and MiniTab.

Managed six quality assurance laboratory technicians.

Regulatory Support:

Prepared responses on statistical issues raised by regulatory agencies when necessary.

Medtech Group, Inc., South Plainfield, NJ (1991 – 1996)

Quality Engineer (1991 – 1996)

Sole responsibility for the quality assurance for the total output of injection molded products for a manufacturer of disposable medical devices. Volume: moderate-eight figure range. Department manager for the Metrology Laboratory. Supervise a staff of Quality Assurance Technicians.

Introduced Statistical Process Control (SPC) providing real time benefits in process monitoring. Results: improved quality, reduced costs and fewer rejects.

Strengthened the concept of prevention rather than the detection of defects.

Fully familiar with computerized integrated manufacturing systems which monitors the process of an injection molding machine. Maximized the use of the system resulting in an immediate identification of potential problem areas.

Contributed to the company’s attainment of ISO 9002 registration.

Maintained the company’s GMP’s and assure operations to SOP standards.

Trilogy Communications, Freehold, NJ (1989-1991)

Manager Quality Assurance (1989-1991)

Recruited to join a start-up manufacturing plant of coaxial cable for the cable television industry.

Recruited, hired, trained and supervised a staff of 11 Quality Control Technicians.

Automated the quality assurance program enabling the company to immediately identify the grade of cable being produced.

Introduced Zumbach controllers, a closed loop feedback system to maintain a consistent diameter product during the extrusion process. Results: a reduction in scrap by 10%.

Served as a troubleshooter on a wide range of customer-related and company-generated technical problems, pinpointing and resolving problems to strengthen customer service satisfaction.

Selected to serve on a transition and training team for six months to install and start up quality control systems for the company’s movement of manufacturing operations from New Jersey to Mississippi.

General Cable Company, Edison, NJ (Research and Development Center) (1984– 1989)

Electrical Engineer II (1984-1989)

Tested and reported data on new telecommunications cable designs used for the Bell and GTE (now Verizon) local and long distance phone networks.

Used various electronic instruments to measure resistance, impedance, cross-talk and other characteristics for communications cable.

Professional Affiliations:

ASQ Certified Quality Engineer (CQE)

ASQ Certified Reliability Engineer (CRE)

Participant “ASQ Certified Reliability Exam Development Process”

Member ASQ

Johnson & Johnson College Recruiter (Rutgers)

Education

Widener University, Chester, PA

Bachelor of Science in Electrical Engineering May 1984

Rutgers University, Piscataway, NJ

Masters of Science in Statistics and Reliability Engineering, January 2006



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