Quality Systems Specialist

Teleflex Incorporated; Ciudad de México; Presencial; MXN 200,000 - 400,000; Jornada completa

Descripción de la vacante

A leading medical technology company in Mexico City is seeking a Quality Systems Specialist to oversee document control processes and manage quality training. The ideal candidate will have proficiency in English, experience in the medical device industry, and a strong attention to detail. This role involves participation in quality system projects, making it essential for candidates to be self-driven and capable of working independently.

Formación

• 2-3 years of experience in medical device industry with FDA and ISO knowledge.
• Computer literate with advanced word processing and spreadsheet skills.

Responsabilidades

• Assess, process, and maintain Quality System documents.
• Provide guidance and assign training to personnel.
• Participate in quality-related projects as required.

Conocimientos

English proficiency

Attention to detail

Document control

Strong proofreading skills

Ability to prioritize projects

Educación

2-year degree preferred

Experience in medical device industry

Herramientas

Agile document management system

ComplianceWire training system

Descripción del empleo

Position Summary

The Quality Systems Specialist will provide professional Quality System Document Control service by processing and maintaining written documents and drawings in accordance with internal procedures and external regulations/standards (ISO 13485, 21 CFR 820, EU MDR and any other regulatory requirements applicable). Provide guidance and assign training to Teleflex personnel. Participate in Quality System related projects as required. Coordinate and manage records management activities for Teleflex.

Principal Responsibilities

• Document Control: Assess, process, and maintain written Quality System documents and drawings in an electronic system.
• Perform Quality Systems Specialist / Change Analyst duties in an electronic documentation management system as needed.
• Review proposed changes, change notes and approvals; edit spelling, grammar and formatting.
• Prepare and process change orders.
• Prepare and process biennial reviews and provide instructions and reminder reports to document owners.
• Maintain databases/indices, distribution, and retrieval systems.
• Assign and track document and other control numbers.
• Assist with document control tracking and metrics.
• Issue periodic status reports (e.g. Overdue Reviews, Issued Documents).
• Training: Assess, process, and maintain Quality System training through an electronic learning management system.
• Process training requests.
• Update and maintain training in an electronic learning management system.
• Provide guidance on training assignments in an electronic learning management system.
• Assist with Quality System training and tracking.
• Participate in Document Control and records retention/storage related activities and projects as required
• Assist with Quality System related document control and training projects as required.

Education / Experience Requirements

• English proficiency is a must (B2 level and above)
• 2-year degree preferred; 2-3 years’ experience in the medical device industry including knowledge of FDA and ISO and other related industry regulations highly desired
• Experience in working with electronic document management system Agile desired
• Experience in working with electronic training system ComplianceWire desired
• Experience working in Quality Systems desired

Specialized Skills / Other Requirements

• Computer literate, (advanced word processing skills;competentin power point, spreadsheet and database applications; comfortable in networked environment).
• Strong proofreading skills.
• Attention to detail and accuracy is essential; good documentation practices.
• Service oriented.
• Able tocommunicatediplomatically and effectively (both verbally and in writing).
• Able to prioritize projects and adapt to shifting priorities.
• Able to clearly provide feedback to department management.
• Self-driven with the ability to work independently and/or as a team player.

At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.

Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, QuikClot, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

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