Senior Quality Assurance Engineer

Responsibilities

• Analyze Quality System data and present established metrics to senior and executive management
• Investigate and resolve quality system corrective actions and preventive actions (CAPA)
• Support internal and external audits to ensure regulatory compliance
• Work with cross-functional teams to develop quality improvement plans and implement changes
• Ensure compliance with ISO 13485, 21CFR 820, and other applicable regulatory standards
• Apply systematic problem-solving methodologies to identify and resolve quality issues
• Utilize Lean, Six Sigma, and other quality tools to enhance product quality and reduce process variance
• Analyze quality audit findings and recommend modifications to products and processes

Requirements

• Bachelor’s Degree in Engineering, a Technical Degree, or an equivalent combination of education and work experience
• 3+ years of experience in CAPA process ownership, including conducting root cause investigations and developing action plans
• Knowledge of FDA, GMP, and ISO 13485 regulations

Preferred Qualifications

• Demonstrated project management and leadership skills with the ability to lead multi-departmental teams
• Strong organizational, follow-up, and attention to detail skills
• Excellent verbal and written communication skills for interacting at multiple organizational levels
• Experience working in a highly matrixed and geographically diverse business environment
• Advanced computer skills, including gap analysis and report writing
• Six Sigma certification (e.g., ASQ CQE, CQA, or similar)

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 specialized student debt/education programs

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 diagnostics, medical devices, nutritionals, and branded generic medicines, serving people in more than 160 countries.