Senior Quality Engineer

About the role

The Senior Quality Engineer, IQA, provides senior quality engineering support for Incoming Quality Assurance activities at our Heredia site. You will ensure patient safety, product quality, regulatory compliance, and continuity of IQA operations while partnering with cross‑functional teams.

Key responsibilities

• Lead incoming inspection processes, material acceptance, and IQA laboratory controls.
• Make independent, risk‑based decisions on product quality and material disposition.
• Identify, investigate and resolve complex quality issues related to raw materials, components, finished goods, and supplier performance.
• Conduct investigations for NCMRs, CAPAs, NCEPs, failure mode analyses, and customer complaints, documenting root cause and corrective actions.
• Interpret technical drawings, specifications, procedures, and quality plans to ensure compliance.
• Support product transfers, new component qualification, inspection method implementation, and process/equipment changes.

Required profile

• Senior‑level experience in quality engineering or incoming quality assurance.
• Proven ability to make independent, risk‑based quality decisions.
• Strong knowledge of regulatory requirements and quality system documentation.

Required skills

• Incoming Quality Assurance
• Root cause analysis
• CAPA and NCMR management
• Nonconformance investigation
• Regulatory compliance
• Technical drawing interpretation