Quality Systems Engineer

Corza Medical; Tijuana; Presencial; MXN 420.000 - 600.000; Jornada completa

Descripción de la vacante

Corza Medical in Tijuana, Mexico seeks an experienced QMS/Audit professional to implement and sustain CAPA and Internal Audit activities within a regulated medical device environment.

You will coordinate internal and external audits, support CAPA investigations, and help drive continuous improvement across the Quality System. Fluent English and Spanish preferred; 3–5 years in QMS required.

Formación

• 3–5 years of QMS experience in medical devices.
• Experience in regulated environments (ISO 13485, 21 CFR Part 820/11).

Responsabilidades

• Create and maintain yearly Internal Audit Program.
• Coordinate and prepare for External Audits (Customer, Notified Body, inspections).
• Support CAPA investigations and follow-up actions.
• Develop and maintain Internal Lead Auditor Certification program.
• Monitor CAPA activities and program effectiveness.
• Provide guidance on internal audit and CAPA processes.
• Prepare quality documentation, metrics, and trend analyses.

Conocimientos

Internal Audit

QMS

CAPA

GMP/GDP

Regulatory Knowledge

Educación

Bachelor's degree in a science/technical field

Herramientas

eQMS

Descripción del empleo

Privacy Policy

Contributes to the development and implementation of strategies and initiatives to support the CAPA (Corrective and Preventive Action) and Audit Quality Programs, ensuring alignment with medical device regulations, standards, and company objectives.

Primary responsibility includes maintaining and improving CAPA and Audit Quality Program activities. This role requires solid experience working in regulated environments (e.g., ISO 13485, 21 CFR Part 820, 21 CFR Part 11) and proficiency in using electronic Quality Management Systems (eQMS).

What we value

• Customer First: We deliver extraordinary experiences.


• Accountability: We do what we say


• Integrity: We do what is right


• Inspired: We love what we do


• One Global Team: We before me, always

What You Will Do (job Duties)

• Create and Maintain yearly Internal Audit Program.


• Support the coordination and readiness for External Audits (Customer, Notify Body, Inspections, etc.)


• Help to ensure the Company is prepared for internal, external and/or customer audits and inspections.


• Participate in the development and maintenance of the Internal Lead Auditor Certification program.


• Contributes to organizational change to create and sustain a work environment conducive to continuous improvement.


• Monitoring and maintaining CAPA activities and Program.


• Assist in CAPA investigations and follow-up actions as needed.


• Provide guidance and support to team members on internal audit and CAPA processes.


• Work on multiple Quality System projects simultaneously.


• Communicates effectively across teams to explain methodology, process, and results from analysis.


• Evaluate the accuracy and conformance to required procedures and performance improvement projects and initiatives.


• Participate in CAPA Board Meetings and provide input on quality issues and trends


• Prepare quality documentation, metrics, and reports by collecting, analyzing and summarizing information and trends, including failed processes, stability studies, recalls, corrective actions and re-validations.


• Schedule Management Review Meeting (s)


• Support to prepared Management Review presentation.


• Other duties as assigned.

What you will need

Education: Bachelor's Degree in a science, technical discipline or Experience equivalent.

Experience: 3-5 years of QMS experience in medical devices.

Languages: English & Spanish - Strong verbal and written communications skills.

Other Knowledge, Skills, Abilities or Certifications:

• Demonstrated experience working with diverse cultures.


• Strong organizational skills. Strong verbal and written communications skills.


• Demonstrated capability/experience raising issues and concerns and constructively challenging leadership to drive appropriate change and compliance.


• Effective communication


• Ability to establish and maintain effective interpersonal relationships at various levels of the organization.


• Experience with GMP, GDP, QMS, Audits, etc. as part of a Quality Culture.


• Effective communication


• Clear report writing, interaction with technical and non-technical areas.


• Teamwork


• Coordination with developers, testers, project leaders.


• Critical thinking


• Assessing risks and proposing evidence-based improvement actions


• Change management


• Ability to lead or facilitate the adoption of process improvements.


• Privacy Policy