Senior Quality Engineer – Incoming Quality Assurance

About the role

The Senior Quality Engineer, IQA provides senior‑level quality engineering support for Incoming Quality Assurance activities at the Cartago site. The role ensures patient safety, product quality, regulatory compliance, and continuity of IQA operations while partnering with cross‑functional teams.

Key responsibilities

• Execute incoming inspection processes, material acceptance activities, and IQA laboratory controls.
• Make independent, risk‑based decisions on product quality and material disposition.
• Investigate and resolve complex quality issues related to raw materials, components, finished goods, and supplier performance.
• Lead investigations for NCMRs, CAPAs, NCEPs, failure‑mode analyses, and customer complaints.
• Interpret technical drawings, specifications, and quality system documentation.
• Support product and in‑country transfers, new component qualification, and process/equipment changes.
• Develop and approve validation protocols, inspection/test method documentation, and related quality records.
• Apply QSR, ISO 13485, risk management, statistical methods, Six Sigma, Lean, and APQP tools to drive continuous improvement.

Required profile

• Senior‑level experience in quality engineering within regulated manufacturing environments.
• Strong ability to make sound, risk‑based quality decisions.
• Proven track record of leading investigations and implementing corrective actions.
• Excellent collaboration skills with manufacturing, engineering, supplier quality, and R&D teams.

Required skills

• QSR (Quality System Regulation) knowledge
• ISO 13485 compliance
• Risk management principles
• Process validation expertise
• Statistical methods and data analysis
• Six Sigma and Lean methodologies
• APQP (Advanced Product Quality Planning)
• CAPA, NCMR, NCEP management
• Root cause analysis and failure‑mode investigation
• Technical drawing and specification interpretation