Quality Engineer Level 1

Title: Quality Engineer Level 1

Location: Pleasanton, CA

100% Onsite

Duration: 12 Months

Responsibilities:

• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• 1- 3 years exp - supports the design, manufacturing, and maintenance of safe, compliant medical devices.
• This role assists senior engineers with validation activities, quality documentation, and problem solving in a highly regulated environment governed by FDA 21 CFR 820, ISO 13485, and ISO 14971.
• Support validation activities — Assist in equipment, process, and software validation (including CSV), troubleshoot discrepancies, and help plan validation efforts using risk-based approaches.
• Document quality issues — Prepare, review, and maintain quality control documents, reports, and production records.
• Participate in CAPA investigations — Support root-cause analysis and corrective/preventive actions under supervision.
• Assist with nonconformance management — Help evaluate product defects, deviations, and material review board (MRB) activities.
• Perform data analysis — Collect and analyze quality metrics to identify trends and improvement opportunities.
• Support audits and inspections — Prepare documentation and participate in internal audits and external regulatory inspections.
• Ensure compliance — Follow established procedures and quality standards in a regulated environment (pharma, biotech, or medical device).
• Collaborate cross-functionally — Work with R&D, manufacturing, and supplier teams to address quality issues and support continuous improvement.

Qualifications

• Bachelor’s degree in Engineering, Biomedical Engineering, Mechanical Engineering, Quality Engineering, or a related field.
• Understanding of FDA QSR, ISO 13485, and basic risk management principles.
• Strong attention to detail, integrity, and accountability in documentation and compliance.
• Ability to interpret technical drawings, procedures, and test methods.
• Proficiency with MS Office and basic statistical tools.
• Internship or co-op experience in medical device, biotech, or regulated manufacturing.
• Familiarity with validation lifecycle, root-cause analysis tools (Fishbone, 5 Whys), and CAPA systems.
• Knowledge of cleanroom or GMP environments.

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.