Quality Systems Engineer (AR)

The Quality Systems

Engineer will support the development, maintenance, and continuous improvement of the company’s Quality Management System (QMS). The role requires strong analytical and communication skills, as well as the ability to collaborate cross-functionally. The ideal candidate has formal training as a lead auditor and has already participated in external audits in ISO standards such as ISO 9001, ISO 13485 (medical), IATF 16949 (automotive), or AS9100 (aerospace).

Key Responsibilities:

• Maintain and improve the Quality Management System in compliance with applicable standards (e.g., ISO 9001, ISO 13485, IATF 16949, AS9100).
• Support the planning, execution, and follow-up of internal and external audits.
• Collaborate with cross-functional teams to investigate audit findings and ensure timely implementation of corrective and preventive actions.
• Manage controlled documents, procedures, forms, and records within the QMS.
• Assist in gap assessments, management reviews, and regulatory readiness efforts.
• Track and report on QMS KPIs and metrics.
• Support training efforts related to quality system processes and regulatory compliance.

Contribute to continuous improvement initiatives across the organization.

Qualifications:

Education:

• Bachelor’s Degree in Engineering, Quality, or a related technical field.

Experience:

• 1–5 years of experience in a quality or regulatory role in manufacturing or regulated industries.
• Formal training as ISO lead auditor (ISO 9001 or equivalent).
• Experience participating in at least one external audit by a customer, registrar, or regulatory agency.
• Familiarity with industry standards (ISO 9001, ISO 13485, IATF 16949, AS9100) and general quality tools.

Technical Skills:

• Good understanding of QMS principles, document control, nonconformance/CAPA systems.
• Ability to interpret and apply quality system requirements.
• Proficient in Microsoft Office and QMS software (e.g., MasterControl, Arena, or similar platforms).
• Strong organizational and written communication skills.

Language:

• Proficiency in English (written and verbal).

Preferred:

• Experience in electronics manufacturing or medical device industry.
• Familiarity with risk management tools (e.g., FMEA, 5 Whys, Fishbone).

Working knowledge of ISO 13485, FDA 21 CFR 820, or related standards

• Beneficios de acuerdo a la LFT
• servicios médicos en planta