Quality Engineer (Medical)

Minimum of a bachelor's degree (BS) in engineering from a four year college or university
- Good written and verbal communications skills English and Spanish
- Preferred experience in medical device industry.
- 3-5 years related experience in similar positions
- Knowledge of ISO 13485
- Domain of root cause analysis tools
- Capable of Leading MRB board
- Ability to administrate calibration of equipment.
- Ability to collect and present Data per the established metrics.
- Experience in developing inspection methods, establishing sampling plans, interpreting customer specifications, TMVs, GR&R, etc.
- Able to challenge processes and work with engineering department to develop manufacturing documentation and validation documents (IQ, OQ, PQ)
- Participate in development of new products, coordination of NPWOS, SWOs (trials for new products)
- Knowledgeable in Statistical tools
- Development of Quality plans, Control plans and Risk files
- Selection, hiring and training of quality personnel. Provides direction and management of daily activities for quality technicians.
- Familiarity with CAPAS, CO's, DHRs, PFMEAs

Tipo de puesto: Tiempo completo

Horario:

- Turno de 8 horas

Tipos de compensaciones:

- Bono de asistencia
- Bono de puntualidad

Lugar de trabajo: In person