Quality Engineer 3

About the role

We are looking for a Quality Engineer 3 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, TMV, OQ, PQ) and produce validation protocols and reports.
• Investigate audit non‑conformances, complaints, and CAPA actions.
• Develop risk management documentation, including Risk Management Plans, Reports, and Process FMEAs.
• Supervise Quality Inspectors/Technicians, assign tasks, and provide training.
• Act as internal auditor for the quality system and support supplier audits and qualifications.

Required profile

• Bachelor’s degree in Engineering, Pharmacy, Microbiology, Physics, Chemistry or related science.
• Bilingual English/Spanish with advanced written and spoken English.
• Knowledge of FDA regulations applicable to medical devices.

Required skills

• FDA regulatory knowledge (IQ, TMV, OQ, PQ).
• Risk Management, FMEA, CAPA.
• Validation protocol development and reporting.
• Quality system auditing and supplier qualification.
• Quality metrics analysis and reporting.
• Advanced English and Spanish communication.

What we offer

• Full‑time position with potential remote work based on business needs.
• Opportunity to work on Class I‑III medical device projects.
• Professional development in a regulated industry.