Quality Systems Specialist

JOB PURPOSE

Work in the coordination of document control (DCRs, CCIDs, CAPAS), Induction training in good documentation practices (GDPs) I also prepare presentations for management review and sterilization release

Provide support in external audits and support in the needs of the area. Review and approve the corresponding responsibilities to ensure that priorities are met in a correct and timely manner.

MAJOR RESPONSIBILITIES

The following information state the main responsibilities of the position but are not limited to. By the other side it is important to indicate that time percentage will vary according to the business needs:

1. Register or modify the documents in the system to comply with global and local requirements.
2. Keep updated the change control and CCIDs to have the quality management system in compliance
3. Provide CAPA tasks to the owner of process to ensure that the investigation report is completed and that the root cause has the instructions and actions should be reviewed.
4. Oversight the sterilization release to manage handling according to the quality procedures.
5. Lead the external audits assuring the compliance QMS vs International Standards included but not limited to ISO:13485for compliance with customer requirements or legality for the manufacture of medical devices.
6. Provide technical information about the current requirements that must be applied in the quality area in alignment with ISO 13485 and EN BS 171415.
7. Realize the new personnel training in compliance with ISO 13485 assuring good documentation practices (GDPs)

Education                        

Bachelor's degree/advanced studies with a major in Engineering or related field.

Knowledge and skills

• High level of knowledge on validations
• Proficient in using CAQ and SAP
• Spoken and written business English
• Knowledge of CAPA
• Knowledge of Audits
• Knowledge of good documentation practices
• Knowledge of CFR 21
• Knowledge of ISO 13485
• Knowledge of Sterilization

Experience      

• 0-3 Years of experience as Doc Control

• External Audit