Title: Quality Engineer
Location: Alameda, CA
Duration: 12 Months
100% Onsite
Summary
We are looking for an experienced Quality Systems Engineer to support and enhance our Quality Management System (QMS). The role focuses on document control, change management, and ensuring compliance with regulatory standards for medical devices and in vitro diagnostics (IVDs).
Key Responsibilities
- Maintain and improve the effectiveness of the Quality Management System
- Manage document control processes, including updates to procedures, work instructions, and templates
- Support change management activities and coordinate with cross-functional teams
- Handle quality investigations such as NCs and CAPAs related to document control
- Ensure compliance with QSR and ISO standards
- Perform document reviews for accuracy, consistency, and format
- Manage multiple priorities and support continuous improvement initiatives
Required Qualifications
- Bachelor’s degree with 4+ years of relevant experience, or 6+ years without a degree
- Knowledge of IVD and medical device regulations
- Experience with document control and change order systems
- Working knowledge of QSR and ISO standards.
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.
