Quality Engineer I

ICU Medical Inc; Tijuana; On-site; MXN 180,000 - 240,000; Full time

Job summary

ICU Medical Inc. is seeking an entry-level Quality Engineer I to support quality assurance ensuring compliance with FDA and ISO 13485 standards across the manufacturing lifecycle.

The role includes investigating product issues, data analysis, and collaborating with cross-functional teams to drive process improvements, registration testing, and GMP/GDP documentation. Bilingual English/Spanish is required.

Qualifications

• University degree in Engineering (Industrial, Biomedical, Chemical, or related field).
• 1 to 3 years of experience in Quality Engineering, Complaints Management and/or Quality Systems.
• Experience with FDA regulations for medical products.
• Excellent oral and written communication skills.
• Bilingual English/Spanish.
• Knowledge of drawing interpretation, statistics, and data analysis.

Responsibilities

• Reviews and investigates product issues and nonconformities.
• Provides quality support for products and project development.
• Acts as a quality representative for transfer products.
• Conduct routine Gemba walks in manufacturing areas.
• Provide feedback to manufacturing engineering to reduce rejects.
• Ensure documentation and processes comply with GMPs, GDPs, and applicable regulatory requirements.
• Formulate, analyze, and present statistical data reports on registrations and tests.
• Provide support in manufacturing process validations.
• Perform inspections and tests of products, raw materials, equipment, or accessories.
• Participate in mandatory meetings and prepare quality documentation.
• Assist in administration of new revised methods.
• Execute and comply with documented quality system requirements.
• Complaints management
• NCMRs management
• Support regulatory enquiries

Skills

Quality engineering

Data analysis

Root cause analysis

Gemba walk

Process improvement

Documentation

Regulatory knowledge

Bilingual EN/ES

Statistics

Education

Engineering degree

Job description

The Quality Engineer I position supports quality assurance activities to ensure compliance with applicable regulatory standards (such as FDA and ISO 13485) and internal quality systems. This entry-level role focuses on collaborating on quality projects, process improvements, and data analysis to maintain and optimize product quality throughout its manufacturing lifecycle.

• Reviews and investigates product issues and/or customer complaints or other nonconformities, including quality system assessments, root cause determinations, and recommends corrective and preventive actions where required.
• Provides quality support for products and project development.
• Acts as a quality representative for quality issues in transfer products.
• Conduct routine walkthroughs (Gemba) in manufacturing areas to identify opportunities for improvement.
• Provide feedback to manufacturing engineering to reduce rejects and non-conforming materials.
• Ensure that documentation and processes comply with GMPs, GDPs, and applicable regulatory requirements.
• Formulate, analyze, and present statistical data reports on registrations and tests developed by your CFT.
• Provide support and assistance in manufacturing process validations at your CFT.
• Perform inspections and/or tests of products, raw materials, equipment, or accessories according to established specifications using special test equipment, including, where necessary, the development of test equipment specifications and protocols.
• Participate in your CFT's mandatory meetings, Tier 2 meetings, and weekly meetings, and prepare and present information and documentation associated with Quality engineering activities.
• Assist in the administration of new revised methods when required.
• Execute and comply with the specific activities and requirements outlined in the documented quality system.
• Complaints management
• NCMRs management
• Support to regulatory enquiries
• University degree in Engineering (Industrial, Biomedical, Chemical, or related field)
• 1 to 3 years of experience in in Quality Engineering, Complaints Management and/or Quality Systems.
• Experience with FDA regulations for medical products.
• Excellent oral and written communication skills.
• Bilingual English/Spanish.
• Knowledge of drawing interpretation, statistics, and data analysis.
• Ability to follow written instructions without special supervision.