Quality Documentation Coordinator 4

Fresenius Medical Care North America; Reynosa; Presencial; MXN 688,000 - 1,033,000; Jornada completa

Descripción de la vacante

A healthcare solutions company located in Reynosa, Mexico, is seeking a Sr. Quality Document Coordinator to manage quality documentation and training procedures. The ideal candidate will possess strong bilingual abilities in English and Spanish, have a high school diploma (or associate's degree), and four years of experience in the medical device or pharmaceutical sector. Proficiency in ISO standards and relevant software like SAP and MS Office is essential. This role may require travel to the U.S.

Formación

• High School Diploma required; Associate’s Degree desirable.
• 4 years’ related experience, preferably in medical device or pharmaceutical organization.
• Working knowledge of ISO standards.

Responsabilidades

• Coordinate approval and modification of design, process, and quality documentation.
• Create and maintain documentation and facilitate record monitoring.
• Interact and communicate professionally with the documentation team.

Conocimientos

Bilingual English/Spanish

Organizational skills

Communication skills

Teamwork

Educación

High School Diploma

Associate's Degree

Herramientas

MS Office Suite

SAP

AutoCAD

Solidworks

Descripción del empleo

Sr. Quality Document Coordinator

Responsibilities

• Under limited supervision, applies considerable Quality Systems knowledge to perform a broad range of tasks which include but are not limited to documentation and training staff on procedures.
• Coordination of the approval, introduction, and modification of design, process, and quality documentation for all products.
• Ability to read, interpret, and apply the company’s quality policy and practices to ensure the documentation being processed meets company standards.
• Ability to read, analyze, and interpret technical drawings, procedures, and other various documents to ensure completeness and correctness.
• Ability to use superior organizational skills, to efficiently get daily and routine tasks completed in a timely manner.
• Ability to interact and communicate professionally with the documentation team.
• Create and maintain documentation. Facilitation of record monitoring, storage, and compliance with all departments.

Qualifications

• High School Diploma required; Associate’s Degree desirable
• Bilingual English/ Spanish (Excellent English communication skills)
• 4 years’ related experience, preferably a medical device or pharmaceutical organization.
• Working knowledge of ISO standards.
• Familiar with Mechanical Drafting Standards
• Proficiency in: MS Office Suites and SAP.
• Works well in team setting as well as individually.
• Guide and develop documentation for team members
• Desirable computer skills: AutoCAD, Solidworks, PDMworks, Visio.
• U.S.A Visa required.
• Availability to travel to the U.S. and other country if required.