What Quality Engineering contributes to Cardinal Health
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
Quality Engineering manages product and service quality planning, evaluation and control. This job family works cross-functionally in the development and implementation of prevention-based methodologies used in designing, manufacturing, testing, and correction of products and services.
Job Summary
Responsible for the validate and transfer new product Compliance and Quality Assurance of the Quality System. Supervise quality trend activities to ensure that the appropriate statistical elements are evaluated in accordance with the requirements of the Quality System
Responsibilities
Responsible for the validate and transfer new product Compliance and Quality Assurance of the Quality System.
Supervise quality trend activities to ensure that the appropriate statistical elements are evaluated in accordance with the requirements of the Quality System
Direct Quality responsibilities: for quality internal and external audits, CAPA site system and document change control.
Support as an auditor for suppliers and manufacturers to comply with QSR / ISO and corporate procedures.
Manage and develop people under his/her supervision. Support the investigation activities of customer complaints.
Approve the quality audit program in accordance with CFR 820 / ISO 13485, and other applicable regulations.
Keep the internal audit procedure updated in accordance with the requirements of CFR 820, ISO 13485, and other applicable regulations.
Qualifications
4-6 years of experience in medical device manufacturing or similar
Solid knowledge of Validation principles and best practices
English: Intermediate Advance
ISO13485 knowledge
BA, BS or equivalent experience in related field
What is expected of you and others at this level
Applies working knowledge in the application of con
📌 Ingeniero de Calidad Sr. (Tijuana)
🏢 Cardinal Health
📍 Tijuana
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