Quality Systems Engineer: GMP & Compliance

Fresenius Medical Care; Región Centro; Presencial; MXN 420.000 - 540.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Career development opportunities

Professional growth culture

Collaborative environment

Descripción de la vacante

Fresenius Medical Care in Guadalajara, Mexico is seeking a Quality System Engineer to support Quality Operations by ensuring compliance with quality system, regulatory and corporate requirements. The role reviews manufacturing and quality records, manages product disposition activities, maintains quality documentation, supports batch release processes, and drives continuous improvement initiatives.

The ideal candidate has a Bachelor’s degree in a related field, at least 1 year of experience,

Formación

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Industrial Engineering, Chemical Engineering, or related field.
• 1 year of experience in a similar position.
• Knowledge of Statistical Process Control (SPC).
• Knowledge of ISO 13485, 21 CFR Parts 210, 211, and 820, and NOM-241-SSA1.
• Proficiency in Microsoft Office applications.
• Knowledge of Quality Systems.
• Knowledge of SAP or similar ERP systems.
• Intermediate English.
• Adherence to established guidelines and procedures.
• Learning agility and capacity to acquire new knowledge.
• Strong interpersonal skills.
• Results-oriented with a focus on achieving goals.
• Problem-solving skills with the ability to develop alternatives and solutions.
• Ability to work under pressure.
• Teamwork and collaboration to achieve results.

Responsabilidades

• Review and disposition finished product and plastic bag batch records.
• Monitor and control finished product lots, including product disposition activities in SAP.
• Verify compliance with parametric release requirements for saline solutions, including export products.
• Review environmental monitoring, water system monitoring, raw material inspection, manufacturing execution, and receiving records.
• Review nonconformances and deviations to ensure quality requirements are met prior to product release or rejection.
• Administer the containment hold system and support batch release activities.
• Maintain, update, and ensure compliance of Quality System procedures with applicable regulations and corporate requirements.
• Organize, maintain, and safeguard Quality Technical Archive documentation.
• Prepare and update procedures supporting departmental activities.
• Comply with site and corporate procedures, policies, safety regulations, and training requirements.
• Participate in continuous improvement initiatives within Quality Operations.

Conocimientos

Strong interpersonal skills

Teamwork and collaboration

Learning agility

Problem-solving skills

Ability to work under pressure

Results-oriented

Adherence to guidelines

Interpersonal skills

Capacity to acquire new knowledge

Educación

Bachelor’s Degree in Chemistry, Pharmaceutical Sciences, Industrial Engineering, Chemical Engineering, or a related field

Herramientas

SAP or similar ERP systems

Microsoft Office

Descripción del empleo

Fresenius Medical Care in Guadalajara, Mexico is seeking a Quality System Engineer to support Quality Operations by ensuring compliance with quality system, regulatory and corporate requirements. The role reviews manufacturing and quality records, manages product disposition activities, maintains quality documentation, supports batch release processes, and drives continuous improvement initiatives.

The ideal candidate has a Bachelor’s degree in a related field, at least 1 year of experience,