Senior Quality Engineer, IQA

About the role

Boston Scientific is seeking a Senior Quality Engineer – Incoming Quality Assurance (IQA) to join its Cartago site. The role ensures patient safety and product quality by overseeing incoming inspection, material disposition, supplier quality, and related compliance activities across multiple business units.

Key responsibilities

• Lead IQA operations, including incoming inspection processes and material acceptance activities.
• Make independent, risk‑based decisions on product quality and disposition of non‑conforming material.
• Investigate and resolve complex quality issues involving raw materials, components, finished goods, and transfer activities.
• Conduct root‑cause analyses, document evidence, and implement corrective and preventive actions (CAPA, NCEP).
• Interpret technical drawings, specifications, procedures, and inspection methods to ensure compliance.
• Support product and in‑country transfers, new component qualification, and implementation of inspection methods.
• Review, develop, and approve process validation documentation.
• Collaborate with cross‑functional teams to maintain an effective quality system and business continuity.

Required profile

• Senior‑level experience in quality engineering within a regulated environment.
• Strong ability to make sound, risk‑based quality decisions independently.
• Proven track record of leading investigations and driving CAPA implementation.
• Excellent analytical skills to interpret inspection, test, and validation data.
• Effective communication and teamwork across multiple business units.

Required skills

• Technical drawing interpretation
• CAPA management
• NCMR investigation
• Process validation
• Inspection method application