Quality Engineer III - Vascular Division

About the role

Abbott Vascular, based in the Costa Rica - Alajuela location, provides minimally invasive, cost-effective products for the treatment of vascular disease. As Quality Engineer III, you will work closely with Manufacturing and Engineering to sustain compliance with quality system requirements and achieve key performance indicators such as NCMRs, MA, yield and cost reduction projects, while supporting and owning process and product validation activities.

Key responsibilities

• Work with R&D and Regulatory Affairs personnel on sustaining activities and new product introduction to ensure product and regulatory compliance.
• Support major quality system investigations (CAPAs, HHEs, StopShip) and internal and external audits, with minimum mentorship from higher-level engineering.
• Conduct technical and statistical investigations on optimization and specification compliance, including NCMR, calibration out-of-tolerance and complaint investigations.
• Execute and author IQ, OQ, PQ and/or PPQ qualifications and inspection and test method qualifications.
• Perform supervisor activities for Quality Technicians if required.

Required profile

• Bachelor's degree in Engineering.
• 2-4 years of experience in Quality or Engineering positions, including at least 2 years in quality or manufacturing engineering roles.
• Experience in FDA, GMP and ISO 13485 regulated environments.
• Intermediate command of English, with fluent oral communication face to face or by conference.
• Shift: administrative.

Required skills

• Proficiency in MS Excel, MS Word and MS PowerPoint.
• Statistical and data analysis, report writing, and knowledge of product and process qualification and validation.
• Process improvement tools such as root cause analysis, fishbone, is/is not, Six Sigma, SPC and quality tools.
• Control of nonconforming material and corrective and preventive actions as investigator and/or implementer.
• Preferred: SAP, ASQ CQE / Six Sigma certification, multi-department project leadership and supervision experience.