Quality Engineer – Medical Devices (Heredia)

About the role

We are looking for a Quality Engineer to support the development and production of Class I‑III medical devices at our Heredia site. The role involves ensuring compliance with FDA regulations, driving process improvements, and leading quality initiatives across product design, manufacturing, and supplier management.

Key responsibilities

• Coordinate new process inspections and collaborate with design, production, and external vendors.
• Prepare and present quality metrics for management and operations reviews.
• Review drawings and tooling, recommending improvements for productivity, quality, and safety.
• Lead qualification and validation activities (IQ, OQ, PQ) for new products and process changes, preparing protocols and reports.
• Investigate audit non‑conformances, complaints, and CAPA actions.
• Develop risk management documentation, including Risk Management Plans, Reports, and Process FMEAs.
• Supervise and train Quality Inspectors, Technicians, and Specialists.
• Act as an internal quality system auditor and support external supplier audits.
• Communicate with customers through weekly reports, QBRs, and project meetings.

Required profile

• Bachelor’s degree in Engineering, Pharmacy, Microbiology, Physics, Chemistry or related field.
• Advanced bilingual proficiency in English and Spanish (written and spoken).
• Strong knowledge of FDA regulations applicable to medical devices.

Required skills

• FDA regulatory compliance
• Risk Management (Risk Management Plan, Risk Report)
• Failure Mode and Effects Analysis (FMEA)
• Corrective and Preventive Action (CAPA) processes
• Qualification & validation protocols (IQ, OQ, PQ)
• Internal and external audit experience
• Supplier quality management
• Quality metrics development and reporting

What we offer

• Opportunity to work on cutting‑edge medical device projects.
• Collaborative, cross‑functional environment.
• Professional development and training.