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Abbott · 4 months ago

Software Quality Engineer II

Los Angeles, CA

Full-time

Onsite

Entry, Mid Level

$82K/yr - $141K/yr

2+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Software Quality Engineer II role is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for non-product software, ensuring compliance with regulatory and business procedures.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

H1B Sponsor Likely

Responsibilities

Provide guidance and training to the site engineers for Non-Product Software development and validation, Data Integrity, Cybersecurity, 21 CFR part 11 requirements and ensure compliance for the same

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 audit

Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

Qualification

Software Quality EngineeringRegulatory ComplianceQuality Management TechniquesProgramming in C/C++/C#Data IntegrityCybersecurityISO 13485Statistical AnalysisSoftware Configuration ToolsInterpersonal SkillsProblem-Solving SkillsProject Management SkillsCommunication SkillsAttention to Detail

Required

Bachelor's Degree in Engineering or Technical Field (Electrical/Computer Engineering preferred) or an equivalent combination of education and work experience

Minimum 2 years roles of Software Quality Engineering experience

Relevant experience, such as Quality, Compliance, Engineering, within a regulated environment, such as medical device, diagnostics or pharmaceutical industries, to develop the competence required to meet the skills and responsibilities of the position

Knowledge of applicable US and non-US Quality System Requirements and other relevant regulations for medical devices. Previous experience with regulatory body. Knowledge of software regulations and compliance (21 CFR Part 11); - Knowledge of ISO 13485

Knowledge of quality management techniques and the application and principles of quality engineering. Strong knowledge and application of concepts, practices and procedures. Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors. Understanding of statistics

Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior

Ability to work independently and in groups; ability to work cross-functionally

Demonstrated initiative and problem-solving skills and critical-thinking skills

Ability and aptitude to use various types of databases and other computer software

Ability to prioritize

Strong organizational and project management skills

Ability or aptitude to lead without direct authority

Programming experience in C/C++/C#, Scripting Language such as Python

Experience with software configuration, and issue-tracking tools such as GIT, Jira, Subversion, ClearQuest, Doors, Bugzilla

Knowledge of FDA 21 CFR part 820, 21 CFR part 11, GMP, IEEE 1012, IEC 62304 and ISO 13485

Advanced computer skills, including statistical/data analysis and report writing

Advanced Information Technology and data mining skills

Ability to work in a highly matrixed and geographically diverse business environment

Ability to work within a team and as an individual contributor in a fast-paced, changing environment

Ability to leverage and/or engage others to accomplish projects

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization

Multitasks, prioritizes and meets deadlines in timely manner

Strong organizational and follow-up skills, as well as attention to detail

Preferred

Medical device experience preferred

Knowledge of Cybersecurity and Data Integrity (ALCOA+) principles preferred

Experience in Bluetooth enabled systems, firmware or embedded software testing and verification/validation preferred

ASQ CSQE certification desired

Benefits

Free medical coverage in our 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

FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

Company

Abbott

Glassdoor3.8

Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.

Founded in 1888

Illinois City, Illinois, USA

10001+ employees

https://www.abbott.com

H1B Sponsorship

Abbott has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2021 (1)