Quality Engineer I

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.

Position Accountability/Scope:

(Influence/Leadership)

Develops working relationships with cross-functional teams to support quality and manufacturing objectives. May participate on project teams and provide input on quality-related activities. Influence is primarily at the team and peer level.

(Planning/Organization)

Plans and prioritizes daily activities to support manufacturing operations, investigations, and project assignments while meeting established timelines.

(Decision Making/Impact)

Exercises judgment within established procedures and guidelines to determine appropriate actions. Failure to achieve objectives or erroneous decisions may impact product quality, compliance, project schedules, or manufacturing performance.

Skills:

• 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.

Education and Experience:

• 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.

This position offers an excellent opportunity for an entry-level engineer to develop technical expertise in manufacturing quality, nonconformance investigations, risk management, quality systems, and continuous improvement within a regulated medical device environment.

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.