Engineer Quality

Lorenzo Rivera

**** ********* *****

Land O' Lakes, Florida 34638

Cell 813-***-****

Email: *******.********@*****.***

OBJECTIVE

_

Seeking a position that will benefit from my analytical, organizational,

interpersonal, project management and technical writing skills within a

manufacturer's Quality Management System.

EXPERIENCE:

OttLite Technologies Inc., Tampa, Florida

Mar 2009 - Present

Quality Manager

Responsible for Quality of High Definition Lighting Products manufactured

in China, ensuring proper Design of product, Manufacturing & Engineering.

. Implemented an ISO 9000 based Quality Management System for Consumer

Products, with concentration on design & development, supplier quality

requirements, first article inspection, and product complaint process

in compliance with the CPSC.

. Developed comprehensive quality procedures and validation protocols

for all products, implemented a data collection and quality metric

system, as well as routine reporting of quality trends based on RMAs

and corrective action reports.

. Implemented shipping inspection, Change Control, Facility Audit, and

Quality Monitoring & Supplier Scorecard processes for China based

manufacturing facilities.

. Coordinate product safety and regulatory product marking approvals -

UL, cUL, ETL, CE, RoHS, WEEE, FCC; ensuring products meet all U.S. and

International requirements.

. Champion continuous improvement efforts for domestic warehousing,

overseas manufacturing assembly, and engineering staffing.

. Champion new U.S. manufacturing, coordinating implementation of

receiving / inspection, product assembly, NCM/MRB, and recycling

processes.

. Collaborate with Sales, Product Sourcing, Marketing, Champion Product

Stewardship Programs, NEMA liaison.

SRI Surgical, Plant City, Florida

Oct 2007 - Mar 2009

Quality Manager

Managed organization's Disposable Products Division quality system with

emphasis on the total quality program, policies and procedures, and

initiatives of the organization; reporting to Sr. VP of Process

Engineering & Quality Assurance.

. Responsible for identifying, analyzing, reporting, and developing

improvements in productivity, quality processes, product recalls,

customer relationships and customer service.

Developed and monitored quality improvements and validation activities

for product design and sterilization process.

. Monitored medical components selection process for new and existing

surgical packs; ensuring components met established FDA guidelines.

Facilitate Quality Steering Committee, 5S liaison, Training, Quality

Pillar, and Six Sigma Project Representative.

Worked closely with inspectors, development of quality personnel, and

managed department budget.

Bausch & Lomb Corporation, Clearwater, Florida

Apr 2005 - Aug 2007

Sr. Quality Engineer (Materials)

Managed Receiving Inspection & Product Release departments on the daily

process of inspections; acceptance of vendor supplied parts & raw

materials; and daily product release activities.

Technical interface with material vendors; communicated part

requirements; resolved technical issues; and developed long-term

inspection plans for raw materials and molded components.

. Supported Quality, Manufacturing, & Engineering to ensure rapid response

of material issues via corrective actions and process control

improvements.

. Managed Plant Nonconforming Material Process and Supplier Complaint

Process.

. Performed quality audits, resolved internal CAPA findings, performed

material & equipment validation/protocols, and drove to completion

projects that impacted the Quality Management System.

Baxter Healthcare Corporation, Largo, Florida

Mar 1995 - Mar 2005

Sr. Project Engineer (8/04 - 3/05)

Planned, executed, directed cross-functional engineering projects, and

prioritized multiple projects and tasks, such as product transfers,

launches, and lean projects.

Constructed detailed, accurate project schedules, interfacing with

development groups and technical support groups in solving project

problems.

. Responsible for developing, documenting, maintaining, and improving

manufacturing processes. Specific tasks included: new technology for

production processes, including inspection processes, leadership and

support for increasing product quality and productivity, supported new

product development and transfer into production.

Sr. Quality Engineer/Receiving Inspection Supervisor (4/03 - 07/04)

Managed the Receiving Inspection department in the daily process of

inspection/test and acceptance of vendor supplied parts and raw

materials.

Technical interface with component vendors to communicate part

requirements, resolved technical issues, and developed long term

inspection plans for molded and machined parts.

. Provided support for sampling, testing methodologies and gage R&R for

incoming components.

. Supplier Auditing, QSR and ISO requirements.

Process Validation & PCA Department Engineer & Supervisor (3/02 - 09/03)

. Lead 23 technicians & assemblers in various capacities throughout Final

Assembly, In-Circuit Test, Functional Test, NCM; leading efforts to

streamline and improve daily production.

. Conducted validation efforts directly with IT, R&D, MFG, QA, Service, and

individual system developers as outlined in the Quality Data Systems

Validation and Process Validation SOPs. This includes performing 21 CFR

Part 11 ERES assessments as appropriate.

. Managed the design and development of new equipment, tooling, and

fixtures to be used in the manufacturing of medical products and the

validation program for all test fixtures within Baxter - Tampa Bay.

. Developed validation plans and protocols related to Quality Data Systems,

manufacturing processes, quality testing, and preventative maintenance.

. Problem solving tools - SPC, Process Mapping, FMEA, Risk Assessment,

Analytical Problem Solving (APS), Pareto Analysis, Kaizen.

Sr. Quality Engineer/Product Analysis Lab/Return Products & Refurbish Dept.

Supervisor (2/00 - 2/02)

1. Supervised diverse group of quality professionals such as engineers,

technologists, technicians, and clerks in the Product Analysis Laboratory

and the Receiving/Sanitization departments.

2. Accountable for leadership & priority setting for tasks associated with

analysis of returned units & parts; gathering of statistical data; and

timely product complaint closure.

3. Monitored the effectiveness of existing processes; inventory reduction;

and status of open product complaints.

4. Provided statistical data to management & product quality meetings for

establishing new trends during failure analysis.

5. Developed, revised, implemented Standard Operating Procedures (SOPs),

and lead cross-functional project improvement teams.

Associate Engineer and Quality Engineer (3/95 - 1/00)

. Supported the Product Analysis Lab in testing and evaluation of returned

parts and devices.

. Worked closely with Medical Specialist in relation to returned parts &

devices, defined final status of product complaints, and aided in

corrective action of products.

6. Provided leadership and support for increasing product quality and

productivity; reducing product cost.

7. Managed failure analysis process for product returned for evaluation and

complaint analysis for Fenwal products.

8. Collected, analyzed, summarized statistical quality data and provided

critical engineering reports.

United States Navy - Naval Air Station Pax River, MD & NAS Jacksonville, FL

Mar 1987 - Jul 1994

Aviation Administration

. Worked for Aviation Administration & Avionics Maintenance departments on

C-130, Boeing 747 aircrafts, and SH-60 helicopters.

EDUCATION:

M.B.A. in International Business - October 1997

Florida Metropolitan University, Tampa, Florida

Bachelor of Science in Electronics Engineering - September 1995

ITT Technical Institute, Tampa, Florida

Six Sigma Green Belt Certified

Baxter E-Learning & Bausch & Lomb Courses:

Project Management

Advanced Project Management Techniques & Fundamentals

IPC-A-610 Acceptability of Electronic Assemblies

FDA Regulations and Device Submissions

Geometric Dimensioning & Tolerancing

SPC; APQP; Measurement System Analysis (MSA); Problem Solving Tools; Mini-

tab

ISO 9001:2000 with Emphasis on ISO13485 Quality Management System - Lead

Auditor Training

ISO 13485, Canadian Med Device Regs, EU Med Device Directives, & Japanese

Pharmaceutical Affairs Law - Lead Auditor Training

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