7 publicaciones de empleo destacadas de patient coordinator en mexico (¡Están contratando!)

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Quality Systems Manager

Ambu -
Ciudad Juárez, Chih.

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Información del empleo

Tiempo completo

Cualificaciones

Administración de personal
Inglés
Licenciatura
Mejora continua
Experiencia en manufactura
Liderazgo

Descripción completa del empleo

City: JUAREZ

Country/Region: Mexico

State:

Business Area: Quality Assurance

Department: QA/RA, Juárez

Employment Type: Full-time

Req ID: 10099

A global job position with an impact:

The Quality Systems Manager is responsible for the oversight, implementation, maintenance, and continuous improvement of the site's Quality Management System (QMS) to ensure compliance with applicable regulatory requirements. This role ensures quality system processes are effective, audit ready, and aligned with business and risk based decision making objectives.

Duties/Responsibilities:

Responsible for managing and monitoring core QMS processes, including document control, change control, CAPA, nonconformances, planned deviations, training, and internal audits.
Ensure the QMS is implemented and maintained in compliance with current regulations and standards according to ISO 13485 and 21 CFR Part 820, and other applicable regulations.
Lead and support regulatory inspections and audits (Notified Bodies, UL, and Corporate), including preparation, execution, and response to observations.
Ensure timely, thorough, and effective investigation and remediation of audit findings.
Maintain and update local QMS procedures to ensure alignment with corporate quality policies and procedures.
Manage the internal audit program to assess the current state of the QMS.
Act as audit coordinator and lead auditor for the site.
Support and contribute to Management Review, providing clear, data driven insight into the continuous suitability and effectiveness of the QMS.
Ensure Management is informed in a timely manner of changes / trends in the QMS regulations and standards.
Ensure corrective and preventive actions (CAPA) activities are risk based, compliant, and effective in addressing root causes and preventing recurrence.
Oversee trending and data analysis of quality metrics to proactively identify systemic risks and improvement opportunities.
Establish, monitor, and report on global and local QMS KPIs and metrics.
Partner with cross functional teams to ensure risk management principles are appropriately integrated into QMS processes.
Provide guidance in all QMS activities such as management review, risk management, training, change management, CAPA system and internal audit program.
Influence fact-based decision making while balancing compliance and business/operational needs.
Develop processes to promote cross functional teamwork and the best use of existing competencies.
Manage, mentor, and develop quality system personnel, fostering a culture of accountability, ownership, and continuous improvement.
Ensure training effectiveness and compliance across the organization for quality system-related requirements.
Promote quality culture and awareness throughout the organization.
Responsible for achieving the goals of Ambu as a whole.
All other duties as assigned.

Authority:

Initiate CAPA's, NCR's and SCAR's based on observations and /or audits
Reject document changes
Stop manufacturing if production represents a quality risk
Put product on hold

Education and Experience:

Bachelor's degree in related field
5+ years of relevant work experience in the medical device field
1+ years' experience in management

Required skills:

Must be able to read, write and understand English
Demonstrated hands on knowledge of ISO 13485.
Proven experience leading regulatory audits and inspections.
Excellent communication, collaboration, and leadership skills
Bachelor's degree in a related field
4+ years of experience working in Quality
Experience in the medical device industry
Experience working in manufacturing preferred
Must be able to read, write, and understand English

How to Apply:
If you are interested in the position, then please apply as soon as possible through our recruitment system. Note that we will invite candidates for interviews on a continuous basis so no need to hesitate.
This job ad will be online until May 25, 2026, but once we have found the right candidate, this ad will no longer be online. For more information about the position, please feel free to contact at [email protected].

About Ambu

Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.

For more information, please visit ambu.com or follow us on LinkedIn.

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patient coordinator empleos en mexico

Quality Systems Manager

IT Site Support Specialist II

Outbound Referral Coordinator

Patient Sales Coordinator

Bilingual Dental Patient Coordinator (Spanish-English)

Medical Customer Service Representative

Remote Executive Assistant - Operations & Communication Focus (LATAM)

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