Quality Senior Engineer

About the role

AbbVie, a biopharmaceutical company focused on immunology, oncology, neuroscience and Allergan Aesthetics, is looking for a Quality Senior Engineer. The role ensures that products are functional and safe for customers by applying quality control systems, improving quality and manufacturing processes, and supporting root cause investigations and process transfers.

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 approvals of high-impact NCR documents
• Develop new quality processes and procedures based on risk-based 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 review and approve quality plans and first article plans
• Propose changes to PFMEAs and review OT Core System documents and validation/qualification protocols (IQ, PPQ, IOQ, IO, PR) as a quality representative
• Support key company projects, define and implement quality controls, and keep assigned areas clean and orderly
• Meet corporate and legal EHS requirements through strategy, internal controls, communication and training

Required profile

• Bachelor's degree in Industrial Engineering, Business Administration or a related field
• At least 3-5 years 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, new procedure definition and risk assessment documentation

Required skills

• Lean tools and statistical knowledge
• PFMEA, IQC, IQ/OQ/PQ, validation protocols
• Project management, critical thinking and data-driven decision making