The Quality Engineer I position supports quality assurance activities to ensure compliance with applicable regulatory standards (such as FDA and ISO *****) 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.ResponsibilitiesReviews 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.Know and apply the policies and procedures of Quality Systems, ISO *****, and any other system required by the company for its operations.QualificationsUniversity 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.Ability to follow written instructions without special supervision.Note: This is a temporary position (5M)
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📌 Quality Engineer I (Tijuana)
🏢 ICU Medical
📍 Tijuana