Quality Engineer II — Medical Devices, CAPA

**Descripción de puesto** Facilitate product and process NCRs and Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring. - Project manage all aspects of NCR/CAPA activity which includes gaining the commitment of cross functional resources, scheduling NCR/CAPA team...

Descripción y detalle de las actividadesExperiência y requisitos- ISO 13485 - Medical Devices Quality Management System (QMS) (ISO 13485 Change Control Program & ISO 13485 CAPA Program) -ISO 11607 (Packaging for terminally sterilized medical devices) -ISO 14971 (Application of risk management to medical devices) -Implementing/maintaining AQL -Six-Sigma...

A global healthcare technology company is seeking a Quality Engineer II in Tijuana, Baja California. The role involves developing and maintaining quality standards, testing procedures, and collaborating with engineering teams to ensure compliance with regulations. Candidates should hold a Bachelor’s degree in Industrial Engineering, have over 5 years of...

EDUCATION and/or EXPERIENCEBachelor's degree in engineering (industrial, chemical, manufacturing, or any other related).And/or 3 years on QA/QC engineering work experience on QA/QC in medical device manufacturing processes such device assembly, injection molding or extrusion, preferable.Preferable ISO 13485 certified internal auditor.CPF-815 (11/23)Knowledge...

EDUCATION and/or EXPERIENCE Bachelor's degree in engineering (industrial, chemical, manufacturing, or any other related). And/or 3 years on QA/QC engineering work experience on QA/QC in medical device manufacturing processes such device assembly, injection molding or extrusion, preferable. Preferable ISO 13485 certified internal auditor. CPF-815...

The Sr. Quality Engineer will be responsible for development procedures and deliverables, ensuring their compliance with ICU Medical quality system requirements and applicable regulations and standards (such as ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations and standards). The Sr. Quality Engineer will provide quality assurance...

The Sr. Quality Engineer will be responsible for development procedures and deliverables, ensuring their compliance with ICU Medical quality system requirements and applicable regulations and standards (such as ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations and standards). The Sr. Quality Engineer will provide quality assurance...

Position Overview The Site Head, Quality is a critical member of the senior leadership team at Outset Medical's Tijuana manufacturing site, responsible for overseeing the Quality Management System (QMS) to ensure compliance with FDA 21 CFR Part 820, ISO , and other global regulatory standards. This role drives quality excellence in the production of Class II...

Position Overview The Site Head, Quality is a critical member of the senior leadership team at Outset Medical's Tijuana manufacturing site, responsible for overseeing the Quality Management System (QMS) to ensure compliance with FDA 21 CFR Part 820, ISO , and other global regulatory standards. This role drives quality excellence in the production of Class II...

Descripción y detalle de las actividades**Position Overview**:The Site Head, Quality is a critical member of the senior leadership team at Outset Medical’s Tijuana manufacturing site, responsible for overseeing the Quality Management System (QMS) to ensure compliance with FDA 21 CFR Part 820, ISO 13485, and other global regulatory standards. This role...