Capa Administrator

Capa Administrator

13 ene
|
Align Technology
|
Chihuahua

13 ene

Align Technology

Chihuahua

ALIGN TECHNOLOGYSolicita: CAPA ADMINISTRATORDescripción y RequisitosResponsible for monitoring, maintenance and improvements to the Corrective / Preventive Actions (CAPA's) including but not limited to the administration of corrective and preventive actions (CAPA's) as well as providing support with the internal audits (as required), ensuring the compliance with the quality management system and regulatory requirements established in the Quality Manual in addition this position will follow-up with the different process owners the effectiveness of the corrective and preventive action (CAPA’s) process.



ROLES AND RESPONSIBILITIES







·Work with multidisciplinary and multifunctional teams to ensure compliance and closure of corrective / preventive actions (CAPA’s-NC’s)



·Review and update information related to corrective / preventive actions (CAPA’s-NC’s) in a timely manner



·Review the corrective / preventive action plans (CAPA’s-NC’s) to ensure that the corrective actions are appropriate to the potential causes or causes identified and provide comments to the owners of the corrective / preventive actions (CAPA’s-NC’s)



·Evaluates and improves the consistency, quality and punctuality in the execution of corrective / preventive actions (CAPA’s-NC’s) through the implementation and maintenance of effective monitoring systems and review mechanisms



·Generates the final report with the conclusions of the investigation of the corrective / preventive actions (CAPA’s-NC’s), ensuring that the report is complete and with the supporting evidence of each of the actions described



·Acts as a facilitator for the monitoring meetings to the corrective / preventive action plans (CAPA’s-NC’s) and manages the implementation activities



·Supports the process of external / internal audits as necessary



·Scale any risk and opportunity for improvement for assessments and decisions additional



·Consider a monthly statistical evaluation of corrective / preventive actions (CAPA’s-NC’s) and identify trends and opportunities for improvement in order to minimize and / or eliminate corrective / preventive actions (CAPA’s-NC’s)



·Performs periodic follow-up audits to verify the effectiveness of corrective / preventive actions (CAPA’s-NC’s).



·Schedule meetings as necessary with the multifunctional teams responsible for investigating corrective / preventive actions (CAPA’s-NC’s) to address areas of opportunity



·Maintains an updated record of corrective / preventive actions (CAPA’s-NC’s)



Experience, formation and education

Bachelor’s degree on Engineering and/ or equivalent in experience

Certified ISO auditor (preferably on ISO13485)

1 year of experience in a similar position

Experience as an auditor (planning and executing audits of the Quality System)

Knowledge in generation, monitoring and reporting of corrective / preventive actions (CAPA’s-NC’s)

Knowledge of the requirements applicable to medical devices (preferably):Quality management systems

ISO 13485

MDSAP

Australian Therapeutic Goods (Medical Devices) Regulations TG (MD)

Brazilian Good Manufacturing Practices RDC ANVISA

Japanese QMS Ordinance MHLW MO 169

FDA Quality System Regulation (21 CFR Part 820)

SOR / 98-282 Medical Device Regulation - Canada

European Council Directive 93/42 / EEC Medical Devices Directives

MS-Office Management (Excel, Word and Power Point).

English level: Suitable to the effective performance of their assigned tasks

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