Quality Assurance Control

Pedro Pastoriza

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

Address: **** ****** **. ***. ****

City: Santa Clara

State: CA

Zip: 95050

Country: USA

Phone: 408-***-****

Skill Level: Experienced

Salary Range: $80,000

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

Pedro L. Pastoriza

2200 Monroe Street, Apartment 1203

Santa Clara, CA 95050 408-***-**** *********@********.***

Objective

To obtain a position in an industrial environment where I may utilize my skills and abilities.

Profile

Experienced and teamwork oriented individual with over ten years in the Medical Devices field, specifically immunoassay and hematology reagents and analyzers. Excellent communication and relationship skills, supported by a strong background in Quality Assurance. Passionate on meeting and exceeding the established business goals. Knowledgeable in ISO 13485:2003, CGMPs, OSHA, FDA regulations (21 CFR -Part 820) and CAPA (Corrective Action, Preventative Action), Microsoft Word and Excel. Biliterate in English and Spanish.

Professional Experience

QUALITY ASSURANCE METRICS ANALYST

2002-2011. Abbott Hematology. Santa Clara, California.

Supported the complaint investigation diagnosis group and the initiation and follow-up of CAPA reports.

Identify root cause and recommended changes for production processes and/or product design to eliminate similar modes of failure.

Responsible for collecting, analyzing customer complaints for the construction and reporting site Quality Assurance metrics.

Tracking and trending of complaints on all Abbott Diagnostics Hematology product line.

Development of databases, spreadsheets and non-product software validation.

Translated engineering investigation methodologies into procedures that can be executed by complaint investigation technicians.

QUALITY ENGINEER

2000-2002. Abbott Hematology. Santa Clara, California.

Determined and established the required procedure for product control and process control including quality and reliability requirements.

Determined methods and procedures for quality measurements utilized by operators, inspectors, auditors, and testers.

Reviewed current methods and procedures to identify possible improvements.

Control of equipment and defective material disposition procedures.

Involved in the validation and verification (IQ, OQ, and PQ) of new production equipment.

Assisted in establishing procedures to ensure adequate preventive maintenance controls.

BIOCHEMICAL TECHNICIAN II, QUALITY CONTROL

1994-1999. Abbott Diagnostics. Barceloneta, Puerto Rico

Performed routine testing of finish products during and after the product shelf life and recalculate as needed.

Calculated, summarized and recorded all stability test data and maintained proper documentation.

Revised and improved quality documents in accordance to ISO and the Quality System Regulations.

Education

INTER AMERICAN UNIVERSITY. ARECIBO, PUERTO RICO.

Bachelor Degree in Science.

Contact this candidate