Quality Engineer I
Abbott
Title: Quality Engineer I Location: Temecula, California Duration: 7 Months Shifts: 6AM TO 2:30PM 100% Onsite Summary: This role provides quality engineering support within a medical device manufacturing environment to ensure the production of safe, effective, and compliant products. The individual will support Manufacturing, Quality Assurance, Operations, and Engineering activities focused on product quality,process compliance, investigation support, and continuous improvement initiatives. What You'll Do:
- Responsible for compliance with applicable Corporate and Divisional Policies and Procedures.
- Provide quality engineering support to manufacturing operations to ensure product quality and compliance with established procedures.
- Support investigations related to nonconformances, product defects, manufacturing deviations, and customer quality concerns.
- Participate in root cause analysis activities and support implementation of corrective and preventive actions.
- Assist with monitoring and analysis of manufacturing quality metrics including yield, scrap, defect rates, and process performance.
- Support continuous improvement projects focused on reducing variation and improving product quality.
- Participate in risk management activities including risk assessments, hazard analyses, and FMEA reviews.
- Assist with development, review, and maintenance of quality documentation, procedures, protocols, reports, and technical assessments.
- Support compliance with cGMP requirements, Good Documentation Practices (GDP), FDA Quality System Regulations, and ISO 13485 requirements.
- Assist with training compliance activities by helping develop and maintain training materials and records.
- Participate in internal audits, external audits, and quality system improvement activities.
- Collect, compile, and analyze quality data to support decision making and improvement initiatives.
- Work with cross-functional teams to address quality issues and support manufacturing objectives.
- Works under general supervision. Follows established procedures. Work is reviewed for soundness of technical judgment, overall adequacy, and accuracy.
- Basic understanding of Quality Engineering principles and Quality Systems.
- Understanding of root cause analysis and problem-solving methodologies.
- Ability to analyze data and identify trends using basic statistical techniques.
- Familiarity with risk assessment and FMEA concepts.
- Ability to read and interpret engineering drawings, specifications, and procedures.
- Strong written, verbal, and interpersonal communication skills.
- Proficiency with Microsoft Office applications, including Excel.
- Ability to work effectively in a team-oriented manufacturing environment.
- Bachelor's Degree in Engineering, Quality, Life Sciences, or related technical discipline.
- 0-3 years of experience in Quality Engineering, Manufacturing Engineering, Quality Assurance, or related field.
- Internship, co-op, or manufacturing experience in a regulated industry preferred.
- Medical device, pharmaceutical, biotechnology, or other regulated manufacturing experience preferred.
- Knowledge of FDA Quality System Regulations, cGMP requirements, and ISO 13485 preferred.
- 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)
- Published on 05 Sep 2026, 10:21 PM
Vacancy posted 4 days ago
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