Quality Manager

hace 4 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
- Ensures that quality system regulations defined in the Code of Federal Regulations - Quality System 21CFR Part 820, ISO 13485:2003 and JPAL are followed.
- Provides adequate resources to meet department objectives and support operations needs.
- Remove barriers which prevent objectives from being achieved and provide managerial and technical support helping others to achieve their assigned tasks.
- Provides input to the department budget and manages to that budget.
- Resolves problems ensuring that quality needs are bing met and manufacturing criteria are adhered to.
- Handles miscellaneous problems that arise, resolves problems with product quality and quality auditing procedures and coordinates the re-work of nonconforming product.
- Prepares written reports summarizing the quality status of product and systems and identifies opportunities for improvement.
- Assists and coordinates the Tech Team as required.
- Manages department personnel by interviewing, hiring, training, evaluating job performance, disciplining, scheduling work and other related responsibilities.
- Reviews risk management files to ensure new risks or risks that have exceeded there thresholds are identified and mitigated.
- 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
- Soldering fumes

SUMMARY OF MINIMUM QUALIFICATIONS
- Educational and or work related experience equivalent to a Bachelor’s Degree in Engineering or related area, ten years of related experience, with proven management skills.
- Demonstrated interpersonal skills and the ability to delegate work.
- Attention to detail and good organizational skills.
- Problem solving and conflict management skills.
- Working knowledge of United States and international standards as applicable to the department.
- Demonstrated computer skills preferably spreadsheets, word processing, database (Oracle preferred), statistical analysis and other applicable software programs.

COMPETENCIES
- Staff training/development
- Supervisory processes
- Computer skills
- Budget
- Scientific research
- Scientific problem solving
- Inventions/new designs/techniques
- Work/project supervision

COMMENTS

Infectious Control Risk Category I:
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 I states employment and procedures that will 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.


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