Software Quality Engineer II at Abbott

Sylmar, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Bachelor’s Degree in Engineering or Technical Field (Electrical/Computer Engineering preferred) or an equivalent combination of education and work experience
Minimum 2 years of Software Quality Engineering experience
Industry certification preferred
Class III or II medical device experience
3-5 years of relevant experience

Responsibilities

Provide guidance and training to site engineers for Non-Product Software development and validation, Data Integrity, Cybersecurity, 21 CFR part 11 requirements and ensure compliance
Work with R&D and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes
Create and execute or direct software validation protocols traceable to system/software requirements
Execute and support on-time completion of Quality Engineering deliverables: test plans (manual and automated), test scripts (manual and automated), test reports
Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems
Assist in the completion and maintenance of risk analysis, focused on software related risks including cybersecurity and data integrity risks
Design and implement various product and process improvement methodologies (i.e., Six Sigma and Lean Manufacturing)
Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving issues
Support internal (corporate and divisional) and external quality audits
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

Skills

Key technologies and capabilities for this role

Quality EngineeringSoftware ValidationRegulatory ComplianceQuality MethodologiesSoftware TestingMedical Devices Software

Questions & Answers

Common questions about this position

What benefits does Abbott offer?

Abbott provides free medical coverage through the Health Investment Plan (HIP) PPO medical plan, an excellent retirement savings plan with high employer contribution, tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit for earning a bachelor’s degree.

Is this role remote or onsite?

This is a fully onsite role located in Sylmar, CA.

What are the main responsibilities of this role?

Responsibilities include providing guidance on Non-Product Software development, validation, Data Integrity, Cybersecurity, and 21 CFR part 11 compliance; creating and executing software validation protocols; implementing code control and defect tracking; assisting with risk analysis; and applying Six Sigma and Lean methodologies.

What is the company culture like at Abbott?

Abbott emphasizes doing work that matters, personal growth, learning, caring for yourself and family, being your true self, career development in an international company, and is recognized as a great place to work, one of the most admired companies, and best for diversity, working mothers, female executives, and scientists.

What salary or compensation is offered for this position?

This information is not specified in the job description.

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees