Descripción y detalle de las actividades
The Sr.
Quality Systems Engineer is the responsible in the development, implementation and follow up of the QMS (MDSAP, ISO***** & FDA 21CFR Part 820) for MXC ensuring compliance to the applicable standards and regulations for the medical devices.
Develop the internal audit program in MXC.
Acts as Auditor Leader during Corporate Internal Audits, FDA, BSI and Customer Audits across all areas of the business.
Responsible for managing the Document Control activities through the EtQ Reliance system to ensure its effectiveness.
Coordinate and follow up the CAPA system.
Coordinate customer complaints investigations and communicate them to team members.
Lead quality projects improvements based on quality data trends.
This position requires strong knowledge in Quality Systems Standards and Regulations (MDSAP, ISO*****, MDSAP & FDA 21 CFR Part 820) in the medical device manufacturing environment.
Experiência y requisitos
Bacherlor Degree in engineeering or equivalent.
Minimum of 3-5 years of experience in Medical Device Quality Systems
Experience in internal/external audits
ENGLISH 90% WRITTEN/SPOKEN
Knowleadge of ISO*****, MDSAP & FDA 21CFR820
Problem-Solving Skills
Certified as an Internal Auditor (Preferably)
- Assure compliance of all applicable Quality System Standards and Regulations (MDSAP, ISO*****, MDSAP & FDA 21CFR Part 820).
- Perform gap assessment to the QMS.
- Implement and maintain Quality Management System and related documentation and procedures for MXC as required.




- Support the goals and objectives of the organization within the Mexicali facility.
- Revise QA complaints in SAP module.
- Interface with complaint corporate department the review of customer complaints.
- Provide leadership and follow up with team members on customer complaint investigations.
- Ensure the integrity of the QMS thru the Corrective and Preventive Action (CAPA) program.
- Coordinate the CAPA system and monitor the process of improvement.
- Generate Trend Analysis Reports for Corporate Quality Management Reviews.
- Auditor Leader for the QMS audit program.
- Facilitate and support external audits from customer and third parties, including tracking and follow-up on audit findings.
- Supports the environmental monitoring process of the cleanroom and prepares results reports.
- Lead and support quality process improvement projects.
- Maintain the Quality Scorecard updated as required.
- Provide training to new employees on the Quality System and EtQ Reliance.
- Support in the planning and execution of the Quality Week activities.
- Participate in the different programs of the organization as required.
Ventajas
- Beneficios de acuerdo a la LFT
**Número de vacantes** 1
**Área** Calidad
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Diurno
**Jornada** Tiempo Completo
**Salario mensual neto** $1,000 - $1,001 MXN
**Estudios** Carrera con título profesional
**Inglés**Hablado: Avanzado, Escrito: Avanzado
**Disponibilidad p.
viajar** No

📌 Sr. Quality Systems Engineer (Mexicali)
🏢 Medline
📍 Mexicali