Quality Engineer II

Responsibilities

• Support the sustainability of commercially released medical products by ensuring manufacturing processes meet quality standards and compliance requirements
• Identify and implement effective process control systems to support product qualification and ongoing manufacturing
• Lead the implementation of assurances, process controls, and CAPA systems
• Apply systematic problem-solving methodologies to identify, prioritize, and resolve quality issues
• Work with cross-functional teams to design and conduct experiments for process optimization and improvement
• Lead the investigation, resolution, and prevention of product and process non-conformances
• Lead and implement product and process improvement methodologies such as Six Sigma and Lean Manufacturing
• Maintain risk analysis and ensure compliance with FDA regulations and Quality Management Systems (QMS)
• Work the 2nd shift schedule: Monday - Thursday, 2:30 PM - 12:30 AM CST

Requirements

• Bachelor’s Degree in engineering, a Technical Field, or an equivalent combination of education and experience
• 2-5 years of Engineering experience with demonstrated use of quality tools and methodologies
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
• Ability to work 2nd shift hours
• Strong verbal and written communication skills with the ability to work in a highly matrixed environment
• Strong organizational, multitasking, and attention to detail skills

Preferred Qualifications

• Prior experience in the medical device industry
• Experience as a CAPA owner or a key cross-functional team member leading a CAPA

Benefits

• Career development opportunities within an international company
• Eligibility for free medical coverage via the Health Investment Plan (HIP) PPO plan
• Excellent retirement savings plan with high employer contribution
• Tuition reimbursement and student debt assistance programs
• Access to FreeU education benefits for obtaining a bachelor's degree

About the Company

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, including diagnostics, medical devices, nutritionals, and branded generic medicines. With 115,000 colleagues serving people in more than 160 countries, we are advancing innovative technologies to help people manage and treat life's greatest health challenges.