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Quality Assurance Engineer Ii

hace 3 semanas

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

1. Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications.
2. Works independently on standard projects while assistance is furnished on unusual problems.
3. Receives instructions on specific assignment objectives, complex features and possible solutions.
4. Responsible for risk management documentation for assigned product line(s) or processes; and identifying and updating failure modes and related process/product improvements by facilitating teams and implementing required changes.
5. Reviews, approves and generates Engineering Change Notifications (ECNs) to update or generate: verification, validation, monitoring and inspection methods, procedures, and test protocols; specific to assigned product line(s) and processes and production control(s).
6. Evaluates and participates in the selection of suppliers by monitoring supplier performance, through collection and trending of data and performing supplier quality audits, as required.
7. Reviews nonconformance records (internal/external) to determine: disposition, root cause and need for corrective and preventive actions.
8. Ensures containment (identification, segregation and reconciliation) of nonconforming product has been performed, to prevent unintended use.
9. Identifies and implements any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system through the use of: quality policy, quality objectives, audit results, analysis of data, etc.
10. Evaluates the work environment, in which product is manufactured, is adequately environmentally controlled and monitored, with sufficient personnel and safety production controls.
11. May participate in design and development activities.
12. Performs other related duties and tasks as required.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
- Lifting - Not to exceed 50 lbs. - local practice may apply.
- Writing
- Sitting
- Standing
- Bending
- Vision
- Color perception
- Depth perception
- Reading
- Field of vision/peripheral
- Fine motor skills
- Noise
- Chemical vapors

SUMMARY OF MINIMUM QUALIFICATIONS
- Education and/or experience equivalent to a Bachelor's Degree in Engineering or related field with three years quality engineering experience
- Strong interpersonal, organizational, and verbal and written communication skills and the ability to work effectively as a team member.
- Demonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO14791, and other medical device related standards.
- Proven ability to work effectively in a team environment through conflict resolution and negotiations.
- Working knowledge of statistical methodologies, quality control and manufacturing tools, such as applied statistics, lean manufacturing, Six Sigma, etc.
- Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.

PREFERRED QUALIFICATIONS
- Medical device experience or equivalent experience in a regulated industry.
- Experience with SmartCAPA, Oracle and Crystal Reports.
- Experience handling deviations, investigations and CAPAs.

COMPETENCIES
- Engineering variable analysis
- Plans/surveys/structures/equipment
- Supervisory assistance
- Special projects/ECN's/prototype creation
- NC causes/corrective actions/dispositions

COMMENTS

Infectious Control Risk Category II:
The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category II states employment and procedures that may require exposure.

Como integrante de Merit, eres elegible a:
Seguro de vida, gastos médicos mayores y gastos funerarios.
Servicio médico en planta extensivo a familia.
Días de aguinaldo, vacaciones y prima vacacional superiores a los de ley.
2 días de permiso con goce al año (1 de cumpleaños y 1 día flotante) *.
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.