Software Quality Engineer - Senior or Lead

Title Software Quality Engineer - Senior or Lead

Location: Pleasanton, CA 94588

Duration: 12 Months | 100% Onsite

Position Overview

The Software Quality Engineer (Senior/Lead) will be responsible for executing and maintaining software quality engineering methodologies while providing quality support for software systems utilized across the division. This role ensures compliance with regulatory standards, drives process improvements, and collaborates cross-functionally to support product development and manufacturing activities.

Key Responsibilities

• Develop and deliver training for divisional software development and validation programs.
• Collaborate with Design and Manufacturing Engineering to complete system/software requirements, verification, and validation activities.
• Create, execute, and/or direct software validation protocols traceable to system/software requirements.
• Implement solutions for code control and administer Code Control and Software Event/Defect Tracking systems.
• Support and maintain risk analysis activities focused on software-related risks.
• Design and implement product and process improvement methodologies (e.g., Six Sigma, Lean).
• Apply systematic problem-solving methodologies to identify, prioritize, and resolve issues.
• Conduct software scoping and Part 11 audits.
• Ensure compliance with FDA regulations, ISO standards, QMS, EMS, and other regulatory requirements.
• Maintain cooperative communication with employees, customers, contractors, and vendors.
• Perform additional related duties as assigned.

Required Qualifications

• Bachelor’s degree in Engineering, Technical Field, or equivalent experience.
• Minimum 5 years of Software Quality Engineering experience.
• Strong knowledge of FDA, GMP, IEEE 1012, IEC 62304, and ISO 13485.
• Advanced computer skills, including statistical/data analysis and technical report writing.
• Experience in Information Technology, data mining, and software tools for validation and tracking.
• Prior medical device experience required.
• Proficiency in software verification, validation, risk controls, and traceability matrix development.

Preferred Qualifications

• ASQ CSQE certification.
• Experience working within large enterprise or cross-division environments.
• Demonstrated ability to work in matrixed, geographically diverse teams.
• Strong organizational, communication, and multitasking skills with attention to detail.
• Ability to adapt in a fast-paced, changing environment.
• Experience with medical device risk management and regulatory compliance activities.

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.