Quality Engineer(CSV)

ZEISS Group; Nuevo León; Presencial; MXN 200,000 - 400,000; Jornada completa

Descripción de la vacante

A leading technology company is looking for a validation and quality expert in Nuevo León, Mexico. You will oversee validation tasks, ensure compliance with regulations, and manage data migration processes. The ideal candidate holds a Bachelor's degree in life sciences or related fields and has extensive experience in Computer System Validation. Strong collaboration and communication skills, as well as GMP knowledge, are essential for success in this role.

Formación

• Bachelor's degree required in relevant fields.
• Experience in CSV strongly preferred.
• Knowledge of GMP in the medical device or pharma industry essential.

Responsabilidades

• Collaborate with CP&R and QUM teams on validation tasks.
• Oversee execution of local CSV according to standards.
• Ensure all deliverables are ready for inspections.
• Conduct IT vendor qualifications and risk assessments.
• Manage data migration validation processes.
• Organize computer system validation training programs.

Conocimientos

Collaboration with international teams

Strong communication skills

GMP knowledge

Experience in Computer System Validation

Educación

Bachelor's degree in life science, medical device or IT

Descripción del empleo

Responsibilities

• As a validation and quality expert, you will collaborate with the China hub CP&R and QUM teams to support all CP&R and QUM-related tasks for each roll-in legal entity in China.
• You will oversee local CSV execution in alignment with approved MVP and LVP standards, demonstrating a proactive approach in working across various workstreams to drive the successful completion of CSV activities.
• Your responsibilities include ensuring that all validation deliverables are prepared and available for NMPA inspections and supporting regulated legal entities in maintaining compliance with GMP/GSP requirements.
• You will work closely with both global and local CIT teams to identify GXP-related systems and infrastructure, conduct IT vendor qualifications, organize risk assessments, and execute system qualifications to ensure that IT infrastructure and applications comply with both local and global validation strategies.
• Additionally, you will manage and coordinate data migration validation processes, safeguarding data integrity throughout migrations.
• You will also prepare GXP-related documentation for FIT 4 China and be responsible for organizing and coordinating computer system validation training programs, providing guidance to workstreams to ensure correct execution of validation tests.
• Critical support for GXP testing is also required as part of this role

Qualifications

• Bachelor degree in life science, medical device or information technology related area.
• Experience in Computer System Validation (CSV) is highly preferred.
• Have basic GMP knowledge in Medical device or Life science or Pharma industry.
• Rich experience inmedical device quality systems, with familiarity of regulations and standards such asISO 13485,GMP and NMPA.
• Fluently in oral and writing English.
• You have a strong ability to work in international and cross-functional teams, paired with a consulting orientation and excellent communication skills.
• Have passion to work in a complex working environment.

Your ZEISS Recruiting Team