5 publicaciones de empleo destacadas en data engineer ii, dash device operations (¡Están contratando!)

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Quality Assurance Engineer II (Molding)

Merit Medical -
Tijuana, B.C.

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Información del empleo

Tiempo completo
Hace 7 horas

Cualificaciones

Word processing
Inglés
Licenciatura
Control de calidad

Descripción completa del empleo

Descripción y detalle de las actividades

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: mold verification, mold validation, monitoring and inspection methods, procedures, and test protocols; specific to mold product line(s) and processes and production control(s).

6. Reviews nonconformance records (internal/external) to determine: disposition, root cause and need for corrective and preventive actions.

7. Ensures containment (identification, segregation and reconciliation) of nonconforming product has been performed, to prevent unintended use.

8. 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.

9. Evaluates the work environment, in which product is manufactured, is adequately environmentally controlled and monitored, with sufficient personnel and safety production controls.

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

Experiencia y requisitos

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 in medical devices.
Prior medical industry experience
Advanced English level
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 handling non-conformances, deviations, investigations and CAPAs.
Experience in revieweing and approving validations for molded products.

COMPETENCIES

Engineering techniques/evaluation/selection/application
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.

Beneficios

Beneficios de acuerdo a la LFT

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SOLICITAR

Número de vacantes 1

Área Calidad

Contrato Permanente

Modalidad Presencial

Turno Diurno

Jornada Tiempo Completo

Estudios Carrera con título profesional

Inglés Hablado: Avanzado, Escrito: Avanzado

Disponibilidad p. viajar No

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Quality Assurance Engineer II (Molding)

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