Position Summary 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. Essential Duties and Responsibilities
• 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
• Provide support and assistance in manufacturing process validations




• 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, 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.
• Evaluate employee performance and recommend any changes to employee status where appropriate.
• Know and apply the policies and procedures of Quality Systems, ISO 13485, and any other system required by the company for its operations.
• This position may have staff reporting to you (Quality Inspectors). Knowledge and Skills
• University degree in Engineering (Industrial, Biomedical, Chemical, or related field)
• 1 to 3 years of experience in quality assurance or engineering in the manufacturing industry.
• Experience with FDA regulations for medical products.
• Excellent oral and written communication skills.
• Bilingual English/Spanish.

📌 Quality Engineer I (Tijuana)
🏢 ICU Medical
📍 Tijuana