Metrology Engineer

Sonova; Mexicali; Presencial; USD 30,000 - 50,000; Jornada completa

Descripción de la vacante

A leading company in medical device manufacturing is seeking a Metrology Engineer in Mexicali. The ideal candidate will ensure strict compliance with regulations while executing calibration activities. This role involves maintaining both routine and non-routine calibrations, supporting audits, and leading process improvements.

Formación

• Minimum 5 years of experience in calibration or metrology in regulated environments.
• Strong understanding of FDA, ISO 13485.

Responsabilidades

• Execute and maintain calibration activities following strict procedures for compliance.
• Lead and support internal and external audits by providing documentation.
• Participate in development and improvement of calibration processes.

Conocimientos

Calibration principles

Traceability

Measurement Systems Analysis

Documentation skills

Communication

Teamwork

Educación

Bachelor's degree in Engineering (Electrical, Mechanical, Metrology, or related field)

Herramientas

Calibration Management Systems

Electronic QMS platforms

Descripción del empleo

We are currently looking for a Metrology Engineer to join our high performance team. This role is critical in ensuring compliance with the strict regulations and standards required for Class III medical device manufacturing.

Key Responsibilities:

• Adhere to the company's Quality Policy and uphold all regulatory and internal quality standards.
• Execute and maintain calibration activities in accordance with strict procedures, ensuring compliance with FDA, ISO 13485, and other applicable standards.
• Accurately document all calibration activities, results, and deviations using electronic systems and calibration logs.
• Ensure proper equipment control by holding stakeholders and team members accountable for their respective roles.
• Foster a culture of continuous improvement — identifying opportunities beyond current achievements.
• Support and prepare for internal and external audits by providing documentation and subject matter expertise.
• Lead, participate in, and support Tier 1 meetings and initiatives to drive daily operational excellence.
• Perform both routine and non-routine calibrations on various systems, including ovens, ESD equipment, ionizers, pressure gauges, timers, calipers, pin gauges, power supplies, and more.
• Oversee in-house calibration activities and coordinate with Original Equipment Manufacturers (OEMs) as needed.
• Manage outbound calibration logistics, including equipment preparation and shipping to external calibration service providers.
• Participate in the development and implementation of new calibration systems and improve existing calibration processes.
• Identify and communicate cost drivers related to calibration changes or vendor price adjustments.

Qualifications:

• Bachelor's degree in Engineering (Electrical, Mechanical, Metrology, or related field).
• Minimum 5 years of experience in calibration or metrology within a regulated environment, preferably medical devices.
• Strong understanding of calibration principles, traceability, uncertainty, and measurement systems analysis (MSA).
• Familiarity with industry standards and regulations such as FDA, ISO 17025, ISO 13485.
• Excellent organizational and documentation skills, with attention to detail.
• Experience working with CMMS (Calibration Management Systems) or electronic QMS platforms.
• Strong communication and teamwork skills.