Quality Engineer 2 – Medical Devices

About the role

This full‑time position supports the development and production of Class I‑III medical devices at our Heredia site. The Quality Engineer 2 works closely with manufacturing, engineering, and supplier teams to ensure compliance with quality standards and regulatory requirements.

Key responsibilities

• Prepare, update, and approve quality documentation linked to Device Master Records and Device History Records.
• Support process validations, risk analyses (FMEA), and CAPA activities.
• Investigate non‑conformances, complaints, calibration issues, SCARs, and environmental monitoring results.
• Maintain supplier quality files and assist with supplier qualifications and audits.
• Execute equipment qualifications (IQ, OQ, PQ, PPQ, TMV) and generate related reports.
• Participate in internal, external, and customer audits, and support readiness activities.
• Develop and review validation protocols and reports for low to moderate complexity qualifications.
• Collaborate on business process improvement and quality system re‑architecture projects.

Required profile

• Experience in quality engineering for medical devices (Class I‑III).
• Familiarity with regulatory requirements and quality system standards.
• Ability to work independently and coordinate cross‑functional initiatives.

Required skills

• FMEA and risk analysis
• CAPA management
• Process validation (IQ, OQ, PQ, PPQ, TMV)
• Document control and quality system compliance
• Supplier quality management and audit support
• Non‑conformance and complaint investigation
• Calibration and environmental monitoring
• Laboratory equipment compliance