Senior Quality Engineer

About the role

AbbVie is looking for a Quality Senior Engineer in Heredia. The role ensures that products are functional and safe for the end customer by applying quality control systems, analysing and improving quality and manufacturing processes, and supporting process quality improvements under the guidance of the area manager.

Key responsibilities

• Evaluate, propose and implement high-complexity improvements in process quality, guided by the area manager.
• Solve manufacturing and process quality problems using Lean tools and support root cause investigations (NCRs), action plans and corrective actions.
• Review and approve documents for high-impact NCRs, quality plans and First Article Plans, and propose changes to PFMEAs.
• Develop new quality processes and procedures based on risk evaluation, and take part in product and process transfer projects from planning to operation, with knowledge of ISO standards and regulations.
• Coach and train colleagues, make high-impact decisions on risk when the manager is absent, and support key company projects including quality controls.
• Maintain clean and orderly work areas, meet quality goals, and comply with corporate and legal EHS requirements.

Required profile

• Bachelor's degree in Industrial Engineering, Business Administration or a related field.
• At least 3-5 years of experience as a quality supervisor or quality engineer in the medical industry.
• Desirable: CQE certification from ASQ; intermediate to advanced English.
• Plus: experience in product transfer, quality systems, validations, manufacturing, procedure definition and risk assessment documentation.

Required skills

• Lean tools and statistical knowledge
• Process quality, validations (IQ, PPQ, IOQ, IO, PR) and PFMEA review
• Project management, critical thinking and data-driven decision making