Quality Engineer II

About the role

The Quality Engineer II will be responsible for ensuring compliance with regulatory requirements and implementing processes to prevent defects and improve product quality.

Responsibilities

• Develop and maintain quality systems and procedures in accordance with FDA regulations and industry standards
• Conduct risk assessments and manage product safety issues
• Support internal and external audits, including corrective and preventive actions (CAPAs)
• Collaborate with cross-functional teams to ensure product quality and regulatory compliance
• Document and communicate quality-related activities and findings

Requirements

• Minimum 3 years of experience in quality engineering within a regulated environment
• Hands-on experience with product risk management, including hazard analysis and risk assessments (ISO 14971)
• Experience supporting complaint investigations, non-conformance evaluations, or health hazard assessments
• Proven ability to collaborate cross-functionally with Engineering, Manufacturing, and Regulatory teams
• Strong analytical, problem-solving, and documentation skills

Qualifications

• Bachelor’s degree in Engineering or related technical field
• Working knowledge of FDA regulations, ISO standards, and quality systems

Skills

• Hands-on experience with product risk management, including hazard analysis and risk assessments (ISO 14971)
• Experience supporting complaint investigations, non-conformance evaluations, or health hazard assessments
• Proven ability to collaborate cross-functionally with Engineering, Manufacturing, and Regulatory teams
• Strong analytical, problem-solving, and documentation skills

Benefits

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

Pay

Compensation is commensurate with experience.

Schedule

This role is 100% onsite.

Contact

To apply, please visit our careers page.

Abbott

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, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Abbott and Talent Solutions

Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives.