Senior Quality Systems Engineer – Medical Devices

About the role

We are looking for a Senior Quality Systems Engineer to support the development and production of Class I‑III medical devices at our Heredia facility. The role involves representing Quality in production processes, driving quality planning, risk analysis, and ensuring compliance with regulatory standards.

Key responsibilities

• Analyze, review, and implement new methodologies, processes, and tools to improve manufacturing and the quality system.
• Lead readiness activities for internal, external, and customer quality audits and maintain audit schedules.
• Manage CAPA files, follow up on corrective and preventive actions, and support investigations of non‑conformances, complaints, and audit findings.
• Prepare quality metrics for management and operations reviews.
• Lead and coach a team of technicians, specialists, and clerks to achieve departmental goals.
• Coordinate and lead cross‑functional quality projects.

Required profile

• Bachelor’s degree in engineering, pharmacy, microbiology, physics, chemistry or related field.
• At least 4 years of experience in a regulated manufacturing environment.
• Bilingual English/Spanish with advanced written and spoken English.
• Strong knowledge of FDA, ISO and other medical‑device regulations.
• Project‑management experience and ability to lead presentations.

Required skills

• FDA regulations
• ISO standards
• CAPA management
• Root‑cause analysis tools
• Internal auditing
• Quality metrics reporting
• Project management

What we offer

• Full‑time, Monday‑Friday schedule (8 am‑5 pm) with potential remote flexibility.
• Opportunities to work on cutting‑edge medical‑device projects.
• Professional development and certification support.