Quality Engineer - Tijuana, México - TACNA/ OUTSET

TACNA/ OUTSET

Empresa verificada

Tijuana, México

hace 2 semanas

Publicado por:

Rodrigo Fernández

Reclutador de talento para beBee

Descripción

Review systems and processes to develop continued improvements through data analysis.

Support or execute change orders for process improvements and determines when process stability and capability studies should be performed on existing processes.
Analyzes and performs failure analysis (investigations) to nonconforming products.
Leads in the implementation of assurances, process controls, nonconformances and CAPA.
Support process validations for manufacturing process. (IQ, OQ or PQ).
Develops and prepares monthly quality trend analysis and reports.
Excellent interpersonal skills.
A selfstarter, motivated and able to positively motivate others.
Focused, target driven with a positive, cando attitude

Bachelor's degree in engineering or technical field or equivalent experience is required.
Minimum of 5 years of quality experience in a medical device or other regulated industry is required.

Knowledge of medical device regulations and standards such as 21 CFR 820, GMP, EN ISO 13485, and ISO
Able to read and understand technical data (drawings, GD&T, etc) Competent using Microsoft Office suites.

Effective analytical, technical, and problem-solving skills. Applies rigorous methodology to complex problems, including six sigma methodology. Ability to multi-task and manage multiple assignments in a timely manner.
Good communication and interpersonal skills. Strong analytical skills.
Sound knowledge of FMEA. Green Belt certification or equivalent a plus.

English : 90%

Certifications
:
SIX SIGMA, GREEN BELT CERTIFIED 21 CFR PARTE 820 Auditor certificado ISO 13485 GMP's para Dispositivos Médicos RISK MANAGEMENT ISO 14971

Skills: