Found Description
Descripción y detalle de las actividades
**RESPONSABILITIES**
- Expertise regarding current regulatory requirements and international standards.
- Performs regulatory and system internal audits to ensure systems are documented, procedures are followed and are adequate according to ISO9001:2015, ISO13485:2016 and 21 CFR Part 820.
- Ensure that all the Quality System Procedures are in compliance with the international standards and regulatory requirements.
- Participate in project development teams and review plans, reports, risk management and design reviews associated with product and process projects.
- Prepares internal audit plans and identifies the roles and responsibilities of audit team members.
- Ensure that internal audit plan is followed and completed according to the approved annual audit plan.
- Participate as Internal auditor leader to develop the rest of the internal auditor’s team
- Follow up corrective / preventive actions generated by internal...
**RESPONSABILITIES**
- Expertise regarding current regulatory requirements and international standards.
- Performs regulatory and system internal audits to ensure systems are documented, procedures are followed and are adequate according to ISO9001:2015, ISO13485:2016 and 21 CFR Part 820.
- Ensure that all the Quality System Procedures are in compliance with the international standards and regulatory requirements.
- Participate in project development teams and review plans, reports, risk management and design reviews associated with product and process projects.
- Prepares internal audit plans and identifies the roles and responsibilities of audit team members.
- Ensure that internal audit plan is followed and completed according to the approved annual audit plan.
- Participate as Internal auditor leader to develop the rest of the internal auditor’s team
- Follow up corrective / preventive actions generated by internal...
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