Quality Systems Engineer

Ambu; Abasolo; Presencial; MXN 420.000 - 700.000; Jornada completa

Descripción de la vacante

Ambu is expanding its Manufacturing Site in Mexico. The Quality System Engineer will support the organization by maintaining CAPA, NCR, and Planned Deviation processes, ensuring inspection readiness, and applying ISO 13485 standards.

The role involves coaching teams on QMS processes, leading quality projects with cross-functional teams, and maintaining quality records and metrics to drive continuous improvement at the site.

Formación

• Bachelor’s degree in a related field.
• 3+ years of relevant work experience in the medical device field.
• 1+ years of experience working in Quality Systems, preferred.
• Hands on knowledge of ISO 13485.
• Experience working in manufacturing preferred.
• Must be able to read, write and understand English.

Responsabilidades

• Ensure compliance of CAPA, NCR, and Planned Deviation processes.
• Serve as site trainer for CAPA and Nonconformances systems.
• Provide coaching and guide teams to follow QMS processes.
• Lead quality projects with cross functional teams.
• Maintain quality records on product testing and stakeholder input.
• Facilitate tracking and closure of Nonconformances to ensure compliance.
• Support development and rollout of standardized QMS data sources and metrics.

Conocimientos

CAPA management

NCR handling

ISO 13485

Quality systems

Auditing

English proficiency

Cross-functional teamwork

Educación

Bachelor’s degree in related field

Descripción del empleo

A Global Job Position With An Impact

We are growing and expanding our Manufacturing Site in Mexico! In the job as Quality System Engineer, you will have the opportunity to actively support the organization by ensuring that our manufacturing site runs as needed to have the growth expected of the products we make in Mexico, excel in your own daily tasks and responsibilities, and experience a very varied working day in a dynamic.

Objective

The Quality System Engineer is responsible to performs quality systems duties, including maintenance of corrective action and preventive action (CAPA), Nonconformance process, planned deviation process among others. Ensures and maintains a state of inspection readiness. Performs in various quality functional areas and maintains expertise.

Duties/Responsibilities

• Ensures compliance of the Corrective Action and Preventative Action (CAPA), NCR, and Planned Deviation processes.
• Serves as site trainer for the Corrective Action and Preventative Action (CAPA) and Nonconformances systems and Planned Deviation process.
• Provide coaching and guide teams to follow QMS processes.
• Leads quality projects with cross functional teams.
• Maintains quality records on product testing, nonconformance, project outcomes, and stakeholder input filed in an accurate and timely manner.
• Makes proposals and assists in the development of corrective and preventative action plans and monitors implementation.
• Facilitates and works with CAPA owners to support the identification of issues, investigations, root cause analysis, action plan development and completion, and verification of the effectiveness.
• Facilitate the tracking and closure of corporate Nonconformances (NCs) to ensure consistency in compliance in areas of evaluation, risk, corrections, timeliness, quality, and thoroughness of content.
• Facilitate quality metrics gathering, analyzing, and reporting on a regular basis.
• Support the development and rollout of standardized QMS data sources and metrics across all levels of the organization of key quality system processes (i.e., Management Review, Corrective and Preventative Actions, monitoring meetings, etc.)
• Conducts investigations, collects data, analyzes trends and prepares reports for assigned quality processes.
• Assesses current quality systems and recommends improvements in order to enhance quality and reduce cycle time.
• Monitors trends, identifies issues, recommends, and implements appropriate actions.
• Assists in the development, implementation, and review of standard operating procedures.
• Maintain current knowledge of the regulations and ISO 13485.
• Has thorough understanding of process criteria and regulations and business impact of decisions and actions.
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics, and compliance always.
• Conduct internal audits as needed and support external audit.
• Includes any other additional duties identified by management required to help and support the quality processes. Complies with Ambu practices.

Required Basic Qualifications

• Bachelor’s degree in a related field.
• 3+ years of relevant work experience in the medical device field.
• 1+ years of experience working in Quality Systems, peferred.
• Hands on knowledge of ISO 13485.
• Experience working in manufacturing preferred.
• Must be able to read, write and understand English.

Work Environment

This is a manufacturing facility and as a result, employees have the potential to be exposed to noise, chemicals, fumes, airborne particles, machinery, vibration, or other workplace hazards controlled within compliance of current safety and health standards.