Review systems and processes to develop continued improvements through data analysis.
- support or execute change orders for process improvements and determines when process stability and capability studies should be performed on existing processes.
- analyzes and performs failure analysis (investigations) to non-conforming products.
- leads in the implementation of assurances, process controls, nonconformances and capa.
- support process validations for manufacturing process.
(iq, oq or pq).
- develops and prepares monthly quality trend analysis and reports.
- excellent interpersonal skills.
- a self-starter, motivated and able to positively motivate others.
- focused, target driven with a positive, can-do attitude
bachelor's degree in engineering or technical field or equivalent experience is required.
*minimum of 5 years of quality experience in a medical device or other regulated industry is required.
* knowledge of medical device regulations and standards such as 21 cfr 820, gmp, en iso 13485, and iso 14971.
*able to read and understand technical data (drawings, gd&t, etc) * competent using microsoft office suites.
*effective analytical, technical, and problem-solving skills.
applies rigorous methodology to complex problems, including six sigma methodology.
* ability to multi-task and manage multiple assignments in a timely manner.
*good communication and interpersonal skills.
* strong analytical skills.
*sound knowledge of fmea.
* green belt certification or equivalent a plus.
english : 90%
certifications*:six sigma, green belt certified 21 cfr parte 820 auditor certificado iso 13485 gmp's para dispositivos médicos risk management iso 14971*
skills: - manejo, resolucion de conflictos y estrés laboral elaboración de fmea ¨s
tipo de puesto: tiempo completo
salario: $1,000.00 - $1,500.00 al día
horario:
- diurno
pregunta(s) de postulación:
- cual es su nível de inglés ?
- cuenta con visa vigente?
- ¿cuántos años de experiência tienes en empresa medica?
experiência:
- quality engineer: 1 año (deseable)