Quality Engineer I
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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.
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