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Abbott · 5 hours ago

Non-product Software Quality Engineer

United States - California - Alameda

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. They are seeking a Non-product Software Quality Engineer responsible for ensuring that computerized systems used in support of the Quality System are developed, validated, and maintained in compliance with regulatory and corporate requirements.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

H1B Sponsor Likely

Responsibilities

Provides Quality guidance in direct support of implementation and maintenance of the nonproduct software lifecycles

Contributes to multiple portions of the Quality System, including but not limited to Master Validation Plans, Impact Assessments, Validation Plans, System Specifications, Requirements, Test Protocols, Test Reports, Trace Matrices, Summary reports, NC/CAPA, and others as needed

Develops and conducts training of company personnel for the divisional non-product software development and validation program

Completes SWQA tasks in accordance with current Quality System Requirements

Works independently with objectives given by manager, planning and coordinating own work to high-level project schedules

Reviews pre-defined deliverables/activities as identified in the SWQA Non-Product Quality Process, Company Policies, or project plans

Reports unexpected events, issues or software bugs which occur during verification/validation to project team and management

Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving issues

Develops and maintains departmental operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, verification, validation and maintenance of computerized systems used in the Quality System as well as those used in the development of ADC software/firmware products

Ensures that appropriate procedures, controls, and disaster recovery plans are incorporated into new computerized systems

Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

Qualification

Quality AssuranceFDA QSR knowledgeISO13485 knowledgeISO14971 knowledgeIEC62304 knowledgeComputer Systems ValidationJiraConfluenceALM Quality CenterASQ CertificationsProblem-solvingCommunication skillsCollaboration skills

Required

Bachelor's Degree, preferably in Engineering, Technical Field, Life Science, or related discipline or an equivalent combination of education and work experience

2+ years' experience in a Quality Assurance or software quality engineering experience in a medical device company

Knowledge of FDA QSR, ISO13485, ISO14971, IEC62304 and FDA Computer Systems Validation (CSV)

Preferred

Knowledge of Jira, Confluence, ALM Quality Center, and/or other software development and test tools is a plus

ASQ Certifications a plus

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)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2021 (1)