**Control of quality system documents and records**:
- Coordinates the updating and maintenance of procedures and other quality system documents.
- Performs issuance and distribution of procedures, work instructions, formats, visual aids and other quality system documents.
- Administers the quality system training system.
- Maintains quality system records; such as: TR's, MRDR's, complaints, CAPA's, GMP's, variances, audit reports and BSI, FDA, COFEPRIS, etc. certificates.
**Quality System Administration**:
- Collaborates in the preparation and coordination of the internal quality system audit program.
- Participates in external audits of the quality management system: ISO 13485, GMP, COFEPRIS, FDA and other regulations.
- Performs internal quality system audits and patrols on good manufacturing practices for medical devices.
**Reports**:
- Prepares monthly QA KPI's report.
- Prepares monthly GMP's and MRDR's report.
- Collaborates with the monthly CAPAs meeting presentation.
- Collaborates with the presentation of the management review meeting.
**Training and Development**:
- Attends all required courses, seminars and workshops in a mandatory and timely manner.
**Other**:
- Follow up of PSR's, complaints and CAPAS.
- Collaborates in specific projects of control and improvement of the quality system.
- Trains department personnel on specific topics.
- Gives induction training to new personnel.
**Job Requirements**:
**Requirements**:
- Industrial Engineer, LAE or related.
- Basic knowledge in blueprint reading and measuring instruments.
- Knowledge of ISO 13485 is desirable.
- Preferably experience in a similar position.
- English language and good writing skills are desirable.
- Knowledge in the use of Microsoft Office.
- Service attitude.
- Availability.
- Communication and training skills.
**Operating Company**:
Ormco