Sr. Quality Systems/CAPA Engineer

Responsibilities

• Assure compliance with corporate and divisional requirements regarding metrics reporting for Management Controls, Management Review, and CAPA quality systems
• Collect, compile, report, and disseminate key quality and compliance metrics and data
• Perform trend analysis of data to determine or assess appropriate actions
• Identify and implement opportunities for continuous improvement within quality system infrastructure
• Redefine quality systems and controls in accordance with US 21 CFR 820 (QSR), ISO 13485, and other international regulations
• Lead non-conformance investigation teams to identify root causes and implement effective CAPAs
• Participate in internal and external audits and assist in preparing for external audit hosting
• Function as part of risk assessment and special project teams to identify compliance gaps and execute closure strategies
• Lead, coach, and mentor entry-level and non-exempt personnel on quality principles

Requirements

• Bachelor’s degree in engineering or a technical field
• Minimum of 5 years of engineering experience with demonstrated use of quality tools and methodologies
• In-depth knowledge of FDA 820, GMP, ISO 13485, and ISO 14971

Preferred Qualifications

• Medical device industry experience
• Project management and leadership skills, including experience leading multi-departmental teams
• Internal and external audit experience
• MS or higher degree in a technical discipline
• Advanced computer skills, including statistical data analysis and report writing
• ASQ CQE or CQA certification

Benefits

• Career development opportunities within an international company
• Health Investment Plan (HIP) PPO medical coverage options
• Retirement savings plan with high employer contribution
• Tuition reimbursement and student debt assistance programs
• Access to FreeU education benefits

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 live their best lives through better health.