Quality Engineer

Job Title: Quality Engineer

Location: Temecula, CA 92591

Duration: 6 Months

Work Arrangement: 100% Onsite

Description:

Position Summary

The Quality Engineer, Regulatory Compliance will support quality system compliance activities to ensure adherence to applicable regulatory requirements, corporate quality standards, and internal procedures. The individual will partner with Quality, Manufacturing, Operations, and other cross-functional teams to drive compliance initiatives, support audits and inspections, manage quality records, and facilitate continuous improvement activities within the Quality Management System (QMS).

Key Responsibilities

• Support compliance with FDA Quality System Regulations, QMSR, ISO 13485, and applicable corporate quality requirements.
• Conduct quality system assessments and compliance reviews to identify risks and improvement opportunities.
• Support internal, external, and regulatory audits and inspections.
• Review and approve quality records, including deviations, nonconformances, change controls, and CAPAs.
• Analyze quality and compliance metrics to identify trends and drive continuous improvement initiatives.
• Collaborate with cross-functional teams to ensure timely closure of quality system actions.
• Support implementation and maintenance of Quality Management System processes and procedures.
• Prepare quality and compliance reports, audit responses, and management review inputs.
• Assist with inspection readiness activities and regulatory commitments.

Required Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or related technical discipline.
• 0-3 years of experience in Quality Engineering, Quality Systems, or Regulatory Compliance within a regulated industry.
• Strong analytical, problem-solving, and technical writing skills.
• Excellent communication and stakeholder management skills.

Preferred Qualifications

• Medical device industry experience.
• Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent certification.
• Experience with electronic quality management systems (eQMS).
• Working knowledge of FDA regulations, Quality Management Systems, and ISO 13485 requirements.
• Experience with CAPA, investigations, change management, nonconformance management, and risk assessment processes.
• Experience supporting audits and regulatory inspections.

Skills

• Quality Systems Compliance
• Audit Support
• Regulatory Compliance
• Data Analysis and Trending
• Risk Assessment
• Technical Documentation
• Cross-Functional Collaboration
• Continuous Improvement

Consultants Eligible Benefits Upon Waiting Period:

• 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)

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.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.