Quality Assurance Auditor Ii

hace 6 meses

Tijuana, México Merit Medical Systems Inc. A tiempo completo

Why Merit?

En Merit Medical, nuestra misión es desarrollar dispositivos médicos innovadores que mejoren vidas. Nuestro objetivo es integrar y desarrollar a gente que quiere construir a través de trabajo duro, en equipo y comprometido, dispositivos que salvan vidas. Juntos estamos haciendo la diferencia en la vida de pacientes de todo el mundo.

ESSENTIAL FUNCTIONS PERFORMED
- Generation and distribution of NC’s for specific area - QAP’s and MPS’s.
- Audits the production process to confirm that Device History Records are completed according to Device Master Record/QSR/GMP regulations.
- Audits finished products to ensure that it conforms with Device History Records/applicable specification and procedures.
- Completes final inspection paperwork.
- Performs work order reviews for ECN's, EPWO's, NC's, etc.
- Documents inspections/rejections on inspection paperwork.
- Segregates product when discrepancies are noted.
- Initiates and ensures closure of NC’s.
- Accountable for the disposition agreement/verification of NC’s.
- Initiates, identifies (labels) and ensures closure of NC’s. Enters information into NC database.
- Operates complex testing equipment in verifying that final product meet specification.
- Performs dimensional inspections.
- Initiates and makes copies of final inspection paperwork.
- Performs product transfers as applicable.
- Tracks and maintains NC's and material testing products.
- Submits materials for MEM/IR testing.
- Performs specification training for production employees.
- Quarantines product when discrepancies are noted.
- Performs work order close-outs.
- Performs other related quality auditing tasks, as required.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
- Lifting - up to 50 lbs
- Writing
- Sitting
- Standing
- Bending
- Vision
- Color perception
- Depth perception
- Reading
- Field of vision/peripheral
- Fine motor skills
- Noise
- Chemical vapors
- Soldering fumes

SUMMARY OF MINIMUM QUALIFICATIONS
- 120 in process credits, including B phase (Experience on products)
- Kardex without incidents (3 previous months)
- Kardex without absences (3 previous months)
- Education and experience equivalent to a high school diploma and a minimum of three years of related work experience with one of the years being in quality assurance/quality control work experience. 9 months minimum as Quality Auditor level I
- Demonstrated knowledge of business mathematics.
- Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.
- Excellent attention to detail and the ability to meet deadlines in a timely manner.
- Communication and interpersonal skills and the ability to work well with others.
- Demonstrates the ability to operate complex test equipment.
- Able to perform all Quality Assurance Auditor functions for one of the following areas:

- Clean Room
- Molding
- Label Control
- IQA

COMPETENCIES
- Production process auditing for specific and general area - PPS’s, QAP’s, MPS’s, and GPS’s
- Finished product auditing
- Basic test equipment operation.
- Final inspection paperwork
- Work order reviews
- Product final inspection
- Generation and distribution of NC’s
- Specification training
- Complex testing equipment operation
- Work order close-outs/sign-offs
- Material testing products/NC tracking, maintenance, labeling
- Auditor training
- Dimensional inspection
- Systems auditing

Como integrante de Merit, eres elegible a:
Seguro de vida y gastos funerarios.

Servicio médico en planta extensivo a familia.

2 días adicionales de festivo (viernes santo y navidad).

Fondo de ahorro sin tope.

Bono anual por resultados.

Comida gratis.

Academia Merit - Capacitación constante.

Comité de Responsabilidad Social.

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