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Quality assurance auditor ii

Tijuana, B.C.
Merit Medical Systems Inc.
Auditor
Publicada el 13 junio
Descripción

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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