Quality Engineer - Medical Device Industry

Sanner America (formerly Gilero); Tijuana; Presencial; MXN 240.000 - 420.000; Jornada completa

Descripción de la vacante

Gilero, A Sanner Company, partners with Tecma, operates a medical device facility in Tijuana, Mexico. Gilero seeks a Quality Engineer to drive QMS effectiveness, CAPA processing, and continuous improvement in a fast-paced environment.

The role requires collaboration with Engineering, Manufacturing, and Regulatory teams to ensure product quality and regulatory compliance across development and production activities.

Formación

• Bachelor’s degree in Biomedical, Industrial, Mechanical or related field.
• Minimum 3 years in a regulated industry (medical devices, pharmaceuticals, or similar).
• Knowledge of ISO 13485 and FDA 21 CFR Part 820.
• Experience with CAPA, NCRs, and regulatory audits.
• Ability to read technical drawings and use precision measurement tools.
• Proficient in Microsoft Office; ERP/QMS experience a plus.

Responsabilidades

• Support QMS development and maintenance per ISO 13485 and FDA 21 CFR Part 820.
• Investigate NCRs, perform root cause analysis, and implement CAPAs.
• Participate in internal and regulatory audits.
• Collaborate with Engineering, Manufacturing, and Regulatory teams to meet quality requirements.
• Review DHRs, incoming inspections, and batch documentation.
• Develop and validate measurement techniques for in-process and finished products.
• Assist with supplier quality tasks and containment actions.
• Contribute to continuous improvement initiatives to enhance quality and efficiency.

Conocimientos

Teamwork

Communication

Attention to detail

Regulatory knowledge

Educación

Bachelor's degree in Biomedical, Industrial, Mechanical or related field

Herramientas

Calipers

Micrometers

Optical comparators

ERP systems

Descripción del empleo

Are you passionate about working to create high-quality, innovative medical and drug delivery devices to improve lives? As a Quality Engineer, you’ll play a crucial role in ensuring the quality of life impacting medical devices and combination products. In this role you will ensure continuous improvement of quality systems while supporting the design, development, transfer, and production of medical device and combination products. Gilero, A Sanner Company, partners with Tecma to operate a medical device manufacturing facility in Tijuana, Mexico. We are currently seeking a Quality Engineer to join the TJ team!

If you thrive in a fast-paced, collaborative environment and like ensuing high-quality outcomes working with customers, vendors, and internal teams, this is the opportunity for you. Join us and be part of a company that values innovation, integrity, collaboration and excellence!

Responsibilities

• Support the development, implementation, and maintenance of the Quality Management System (QMS) in compliance with ISO 13485 and FDA 21 CFR Part 820.
• Assist in the investigation and documentation of non-conformances (NCRs), root cause analysis, and implementation of corrective and preventive actions (CAPAs).
• Participate in internal audits and help prepare documentation for regulatory and customer audits.
• Collaborate with Engineering, Manufacturing, and Regulatory teams to ensure quality requirements are met during product development and manufacturing.
• Review and approve Device History Records (DHRs), incoming inspection results, and production batch documentation.
• Develop and validate measurement and inspection techniques for in-process and finished medical device products, ensuring accuracy, repeatability, and compliance with product specifications and regulatory requirements
• Support production line troubleshooting by identifying quality issues and assisting manufacturing and production teams with containment and resolution.
• Participate in validation activities (IQ, OQ, PQ) for manufacturing processes, equipment, and quality control systems.
• Contribute to writing and updating quality procedures, inspection instructions, and work instructions.
• Assist with supplier quality tasks, including incoming inspections and supplier assessments.
• Engage in continuous improvement initiatives aimed at enhancing product quality, process efficiency, and compliance.

Skills/Qualifications:

• Bachelor’s degree in Biomedical, Industrial, Mechanical or a related technical field.
• Minimum 3 years of experience in a regulated industry (preferably medical devices, pharmaceuticals, or similar manufacturing environments).
• Knowledge of quality and regulatory standards, such as ISO 13485 and FDA 21 CFR Part 820.
• Familiarity with inspection tools such as calipers, micrometers, optical comparators, and other precision measurement equipment.
• Ability to read and interpret technical drawings, specifications, and inspection instructions.
• Understanding of validation principles (IQ, OQ, PQ) and quality assurance methodologies.
• Exposure to root cause analysis tools and corrective/preventive action (CAPA) processes.
• Proficiency in Microsoft Office (Excel, Word, Outlook); experience with ERP or QMS systems is a plus.
• Strong teamwork skills, with a hands-on, detail-oriented approach.
• Excellent communication skills (oral and written). Proficient in conversational English.

Personal Attributes:

• Meets Gilero Core Values of Collaboration - embracing teamwork and transparency in our organization, partnering with our customers and vendors; Integrity - doing the right thing at all times; fair and trustworthy; always keeping the patient in mind; Innovation - open to new ideas, processes, and solutions; leveraging technology to creatively solve problems and Excellence - delivering exceptional products and services with passion and pride.
• Comfortable and productive in a fast-paced, entrepreneurial environment
• A self-starter seeking a career opportunity with potential for internal advancement, seeking
• Commitment to excellence and quality service to external and internal customers
• Follow established policies and procedures, while contributing to continuous improvements

Why work at Gilero?

Founded in 2002, Gilero, a Sanner Group company, is an international contract engineering firm that specializes in the design, development, and manufacturing of novel medical devices and drug delivery products. At Gilero we are proud of the culture we have built that directly reflects our values of excellence, integrity, innovation, and collaboration. Motivated by our purpose to benefit people and improve patient outcomes, our team continue to grow at a rapid pace. Locations include Tijuana, Mexico and US locations in Carlsbad, CA; Chicago, IL; as well as NC locations in Raleigh, Durham, Greensboro, and Pittsboro.