Quality Superintendent (480174)

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CareerMine Job Id: 657381 Job Summary
Title:	Quality Superintendent (480174)	Employer Job Id:	-------
Location:	Baja California	Posted Date:	January 3, 2012
Employer:	Subscriber - Log In to see Company Name	Closing Date:	March 4, 2012

Quality Superintendent (480174)

Requirements:

Bachelor Degree (Industrial Engineering, Business Administration.)
Bilingual
Black Belt certification.
Quality experience
US Visa

Responsibilities:

Ensure compliance to internal and corporate procedures, appropriate FDA and international regulations and standards through design of robust quality systems.
Coordinate the alignment of Quality specifications with proper defect classification and sampling plans. Support Process / Product Validations (IQ, OQ, PQ FAT, Dispositions, Equivalences, Software) by reviewing and approving protocols, determining statistically valid sampling, analyzing validation data and reviewing and approving final reports.
Complete the quality documentation in activities like transfers and NIP (DMR, Procedures, specifications, etc). Supervise QA trending activities to ensure proper statistical elements are used.
Evaluate the quality device impact in rework operations.
Conduct test method validations using Gage R&R, and similar statistical techniques to ensure proper repeatability and reliability of test methods. Conduct investigations into process and product failures to determine root cause and assist in the implementation of corrective actions.
Prepare quality engineers to comply with ASQ CQE certification requirements.
Train Quality associates in basic statistical techniques. Support as auditor to suppliers and contract manufacturers for conformance to (QSR,ISO 13485 y GMPs) and Corporate procedures.
Support the Engineering, Manufacturing and Quality personnel with proper statistical rationales for evaluation studies, validation and sampling plans. Support Engineering, Manufacturing and Quality personnel with R&R & DOE studies.

Experience Required:

5 - 10 years of experience managing the area in a regulatory environment-
CFR 820 / ISO13485 - ISO3
Risk Management
Strategic Project Management
Innovation management
Developing direct labors
Total work systems
Building effective teams
Developing direct labors
Total work systems
Experience in Customer compliance inspection/ Process/ Product and business strategy development.
Experience in medical industry

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