Quality Assurance Engineer Iii - Tijuana, México - Merit Medical Systems Inc.
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
- Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications.
- Investigates a moderate number of engineering variables in completing assignments that have clear and defined objectives.
- Works independently on standard projects while assistance is furnished on unusual problems.
- Responsible for risk management documentation for assigned product line(s) or processes; identifies and updates failure modes and related process/product improvements by facilitating teams and implementing required changes.
- 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).
- 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.
- Reviews nonconformance records (internal/external) to determine: disposition, root cause and need for corrective and preventive actions.
- Ensures containment (identification, segregation and reconciliation) of nonconforming product has been performed, to prevent unintended use.
- 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.
- Evaluates the work environment in which product is manufactured, and ensures it is adequately environmentally controlled and monitored, with sufficient personnel and safety production controls.
- May participate in design and development activities.
- Performs other related duties and tasks as required.
- 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 five 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.
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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