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Victor Rodriguez

Quality Assurance Director - Accellent Inc

El Paso, TX

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Authorized to work in the US for any employer

Work Experience

Quality Assurance Director

Accellent Inc
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March 2010 to March 2015

Manage Quality Assurance Department for multiple sites with direct supervision of (6) Quality Assurance Managers and overall responsibility quality systems for all sites. 
 
Responsible for ISO 13485, QS 9000, FDA Quality Systems Regulation, PAL-Japan QSR In charge for Regulatory Affairs change control system. 
 
Manage Supplier Quality, Customer Complaints & Quality Engineering Responsible for Quality Improvement Program, Document Control & CAPA Systems Accountable for Environmental Control Program Lean Manufacturing Program 
 
Statistical Technical support to manufacturing in the areas of New Product Introduction, Process Development, Validation and SPC systems. 
Responsible for Technical Assistance and Training on Lean Manufacturing & Six Sigma Program utilizing statistical tolls such as, VSM, 5S, TPM, PFMEA, DOE, QFD, C&E Analysis, Process capability Studies, Process Validation, PPAP, SPC, Poka Yoke, and Control Plans. 
 
Product lines: Contract manufacturing for Endoscopy / Laparoscopy / Orthopeadic devices. 
Key Processes: Ultrasonic welding, Solvent, Locktite & UV bondng. Medical device assembly & packaging. 
 
Form, Fill & Seal packaging equipment. Simpulse & hot bar sealing. Pouch & header bag sealers. 
 
Gamma radiation & EtO sterilization contract manufacturing.

Sr. Quality Assurance Manager

BARD / DAVOL Surgical Innovations
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October 2001 to June 2009

Manage Quality Assurance Department with direct supervision of (12) Quality Engineers, (2) Quality supervisor, (2) Supplier Quality Engineer, (2) Quality Systems Engineers, (30) quality control inspectors and (8) metrology lab technicians. 
Responsible for ISO 13485, QS 9000, FDA Quality Systems Regulation, PAL-Japan QSR In charge for Regulatory Affairs change control system. 
Manage Supplier Quality, Customer Complaints & Quality Engineering Responsible for Quality Improvement Program, Document Control & CAPA Systems Accountable for Environmental Control Program Lean Manufacturing Program leader - Lean Master The QA group under my responsibility: 
Provide Statistical Technical support to manufacturing in the areas of New Product Introduction, Process Development, Validation and SPC systems. 
Responsible for Technical Assistance and Training on Lean Manufacturing & Six Sigma Program utilizing statistical tolls such as, VSM, 5S, TPM, PFMEA, DOE, QFD, C&E Analysis, Process capability Studies, Process Validation, PPAP, SPC, Poka Yoke, and Control Plans. 
 
Product lines: Laparoscopy/Orthopeadic devices. Blood transfusion devices. Catheter securement devices. Surgery Custom Kits. 
Key Processes: Ultrasonic welding, Solvent, Locktite & UV bondng. Electromechanical & PC board assembly. Form, Fill & Seal packaging equipment. Simpulse & hot bar sealing. Pouch & header bag sealers. 
Automated equipment for catheter securement assembly & packaging. Lamination, printing & die cutting web transfer automated equipment. 
Gamma radiaion & EtO sterilization processes.

Quality Assurance Manager

PEC, Inc
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El Paso, TX
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November 2000 to September 2001

Manage Quality Assurance Department with direct supervision of (3) quality engineers, (1) quality supervisor, (16) quality control inspectors and (4) metrology lab technicians. 
Responsible for ISO 9000, QS 9000, FDA Quality Systems In charge of Supplier Quality, Customer Technical Service, APQP & PPAP System Manage Quality Improvement Program, Document Control, CAPA & Customer Complaints Systems. 
 
Product lines: Medical device molding components. 
Key Processes: Molding & extrusion.

Quality Assurance Manager

Johnson & Johnson
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El Paso, TX
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April 2000 to August 2000

Manage Quality Assurance Department with direct supervision of (4) quality engineers, (5) quality supervisors, (62) quality control inspectors in a three shift operation. 
Manage Quality Improvement Program, CAPA & DPMO Improvement Teams.

Quality Engineering Manager

J&J
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El Paso, TX
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January 1997 to April 2000

Manage Quality Engineering department with direct supervision of (5) quality engineers, (2) quality technicians supporting two manufacturing plants. 
Provide Statistical Technical support to manufacturing in the areas of New Product Introduction, Process Development, Validation and SPC systems. 
Responsible for Technical Assistance & Training of Six Sigma Program utilizing statistical tolls such as PFMEA, DOE, QFD, C&E Analysis, Process capability Studies, Process Validation, PPAP, SPC, Poka Yoke, & Control Plans. 
Manage Supplier Quality & Incoming Inspection departments, including Vendor and Part approval process. 
Responsible for Cost Reduction Programs with annualized savings over $1.5MM.

Staff Technical Service Engineer

Poka Yoke and Continuous Flow Manufacturing
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January 1992 to January 1997

Provide technical assistance for resolution of Customer Complaints by implementation of effective C/A's & P/A's resulting in a 30% complaints reduction. 
Improve process & equipment through statistical process analysis, Poka Yoke and Continuous Flow Manufacturing, Equipment FMEA & PM programs. 
Implementation of Cost Reduction Programs in the areas of supplier raw materials and manufacturing processes with annualized savings of $800K. 
 
Product lines: Gowns, Drapes & Gloves devices. Custom surgery kit packaging. 
Key Processes: Non-woven web transfer processes. Ultrasonic welding, Solvent, Locktite & UV bondng. Latex & silicon dipping process for glove manufacturing. Automated glove packaging equipment. FFS & impulse sealers. 
Gamma radiation & EtO sterilzation processes.

Sr. Technical Services Engineer

Johnson & Johnson Critikon
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El Paso, TX
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January 1989 to January 1992

Development and Implementation of Manufacturing Processes, Process & Equipment Specifications and PM programs. 
Manufacturing start up of six semi-automated production lines, $650K project. 
Product testing & evaluation for OEM customers, Materials Sourcing & Evaluation. 
 
Product lines: Blood monitoring devices. Blood Pressure Cuff devices. Custom Design blood devices. 
Key Processes: Pad & silkscreen printing equipment. Ultrasonic welding, RF welding. Solvent, Locktite & UV bondng. Electromechanical & PC board assembly. Pouch Seal packaging equipment.

Manufacturing Engineer

Inspiron / Intertech Resources, Inc
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Ontario, CA
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December 1986 to January 1989

Engineering support to injection & blow molding operations, in areas of process/equipment set ups, and part approval. 
Injection molding transfer to new facility, coordination of equipment layout, installation, production start up of 12 machines. 
Installation & Validation of blow molding operation for Sterile Water Container system under class 100 clean room. 
Product lines: Respiratory care devices, Nebulizers, Tracheal scopes, Masks and Sterile bottle water & saline bags. 
Key Processes: UV water treatment. Sterile water systems. Bottle blow molding under clean room conditions. Automated maskassembly & packaging.

Manufacturing Engineer

OMEDA Medical Engineering
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Atlanta, GA
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June 1984 to December 1986

Manufacturing support to Electro-Mechanical assembly lines, process included PC board assembly & wave soldering. 
Responsible for Maintenance of mechanical production equipment. 
 
Product lines: Operation Room (OR) gas delivery systems. Oxygen, Air & Nitrogen pipelines & quick wall connectors. Oxygen monitoring devices. OR floor control alarm devices. Neonatal Incubators. 
Key Processes: Electromechanical assembly equipment. Rotary die assembly & PC board wave soldering process. Form, Fill & Seal packaging equipment.

Manufacturing Engineer

RCA Electronics
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El Paso, TX
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January 1982 to June 1984

Manufacturing support to electronic device assembly lines, process included automated insertion, wire hardness & wave soldering and mechanical assembly. Coordination of product changes & product specifications.

Education

Master in Mechanical Engineering

University of Texas at El Paso -
El Paso, TX

1984

Bachelor in Science

University of Texas at El Paso -
El Paso, TX

1982

Additional Information

Robust experience of 25+ years in areas such as Manufacturing, Product Development, Technical Services, Supplier Quality, Quality Engineering, Quality Systems, Quality Assurance and Management Strong exposure to medical devices manufacturing and vast expertise in ISO 14385, QS 9000, GMP's, FDA, […] PAL-Japan QSR Quality Systems & Standards, Six Sigma Methodology & Statistical Tools. 
Results oriented professional and proven team leader in high volume manufacturing with strong management skills. 
Master Degree in Mechanical Engineering, ASQ Certified Quality Manager (CQM), Certified Quality Engineer (CQE), Six Sigma Black Belt and Lean Master. 
Bilingual Spanish and English