Quality Engineer

Thermo Fisher Scientific (Planta Tijuana); Tijuana; Presencial; MXN 729,000 - 1,004,000; Jornada completa

Descripción de la vacante

A leading global scientific company in Tijuana is seeking a Quality Supervisor to oversee quality assurance processes and coordinate various plant activities. The ideal candidate will have a Bachelor’s degree in Engineering or Science, at least 3-5 years of experience in ISO certified medical-device manufacturing, and strong skills in statistical software. Responsibilities include managing quality inspections, leading CAPA investigations, and ensuring compliance with ISO standards. Strong English communication skills are essential.

Formación

• 3-5 years of experience in ISO certified medical-device manufacturing.
• Hands-on experience in CAPA process.
• Knowledge of ISO 9001 and ISO 13485 standards.

Responsabilidades

• Coordinate inspection and testing of products.
• Lead CAPA investigations and audits.
• Supervise a group of Quality inspectors.

Conocimientos

Problem-solving techniques

Statistical software knowledge

Advanced English

Knowledge of Lean manufacturing

Educación

Bachelor degree in Engineering or Science

Certificated in ASQ, Six Sigma

Herramientas

Minitab

MS Office (Word, Excel, Access, PowerPoint)

Descripción del empleo

Responsibilities

• Coordinates subordinates in the inspection and/or receiving testing and/or process and finished products, according to established procedures.
• Coordinates Tijuana plant activities related to customer complaints.
• Coordinates customer-complaint related CAPA (Corrective Action & Preventive Action) at the Tijuana plant. Works with various departments to identify the root cause of problems, define the necessary actions required to assure corrective and preventive actions are properly implemented and documented.
• Perform the task of verification of the effectiveness of the CAPAs.
• Participate in the process and product improvement plans.
• Participates actively to cost reduction and PPI programs.
• Give support to Quality Assurance & Quality Manager to attend observations of ISO 9001 and ISO 13485 certification process apply to his area.
• Coordinates the initiation and closure of internal non conformances (NCMs).
• Participates/Leads CAPA investigation.
• Participates/Leads internal audits.
• Participates/Leads internal and external (customer) meetings as required.
• Supervises a group of Quality inspectors.
• Conducts trend analysis.
• Other duties may be assigned, as required.

Qualifications

• Bachelor degree in Engineering or Science or equivalent training and/or experience, with focus on Industrial Engineering and/or Quality Engineering.
• MS Office (Word, Excel, Access and PowerPoint) intermediate level.
• Statistical software knowledge (minitab).
• At least 3-5 years of experience in an ISO 9001 and/or ISO 13485 certified medical-device manufacturing company.
• Injection molding.
• Knowledge of Lean manufacturing process.
• Hands‑on experience in CAPA Process.
• Experience with Failure Mode and Effect analysis tools.
• Experience with problem‑solving techniques such as Fishbone diagram, Process Review, C&E, 5 Whys among others.
• Knowledge of ISO 9001 and ISO 13485 standards.
• Advanced English Level (Reading, conversation, able to do fluid presentations).
• Certificated in ASQ, Six Sigma, ISO 13485 Internal/Lead auditor. (Desirable)

Validaciones, Bases estadísticas, experiencia en moldeo por inyección,