Staff Quality Engineer

Responsibilities

• Develop and implement quality engineering strategies to ensure high-quality product delivery
• Reduce manufacturing defects by leading root cause analysis and implementing CAPA through structured problem solving
• Utilize quality tools including Gage R&R, Cp/Cpk, and Statistical Process Controls (SPC)
• Lead Design Verification and Validation (V&V) activities, including planning and execution
• Manage method validation activities such as IQ, OQ, PQ, and PPQ protocols
• Ensure Design History File (DHF) integrity and compliance with FDA 21 CFR 820 and ISO 13485
• Supervise, develop, and lead junior Quality Engineers
• Identify process improvements through data analytics and implement early warning systems to reduce variation

Requirements

• Bachelor's degree in Engineering or a related field
• Minimum 9 years of related work experience in a quality engineering role
• Deep knowledge of FDA 21 CFR 820 and ISO 13485 standards
• Expertise in Gage R&R, Cp/Cpk, and Statistical Process Control (SPC)
• Proven experience with IQ, OQ, PQ, and PPQ validation processes

Preferred Qualifications

• Experience in the medical device industry
• Demonstrated expertise in statistical analysis and problem-solving techniques
• Six Sigma Green Belt or Black Belt certifications

Benefits

• Career development opportunities within an international company
• Medical coverage through the Health Investment Plan (HIP) PPO plan
• 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. We serve people in more than 160 countries with a mission to advance innovative technologies in healthcare.