Sr. Software QE at Abbott

Queretaro, Queretaro, Mexico

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, ElectrophysiologyIndustries

Requirements

Bachelor's degree in Engineering, Science or Technical Field
5 - 6 years of experience

Responsibilities

Supports customers on non-product software validations for accuracy, adequacy, and compliance with the non-product software development lifecycle, Quality System, Part 11, Data Integrity, Cybersecurity and FDA regulations
Execute, reviews and support on-time completion of Software Quality Engineering deliverables: software requirements, validation test plans, code reviews, test scripts, test reports, software inventory reports
Manage and leads test planning and execution efforts by a combined team of testers located onsite and/or offshore
Establishing & maintain strong trust-based peer relationships cross-functionally
Supports and/or leads cross-functional project teams (local or international) related to non-product software and quality improvements
Based on key performance indicators data, may support activities focused on maintaining indicators under control for CTQ, budget or other indicators deemed necessary
Represents the SW QE department on a CAPA investigation teams and can lead high complexity root cause issue investigations related to software
Provides guidance, leads, supports development and retention of other software quality engineers
Serves as the primary site representative for external regulatory inspections and audits in case of absence of a Software Quality Engineer Lead, Software Quality Manager, or higher representative rank in relation to non-product software related audits
Can perform other assignments according to the requirements of the business or upper management
With minimum supervision, design software requirements, protocols, test plans, scripts, and reports to validate non-product software, using the non-product software development life cycle procedure
Identify, analyze, and document software validations to meet current regulations and medical industry standards
Provides guidance, maintain, leads and/or develops other software quality engineers in the Non-product software Lifecycle
Apply the software quality methodologies to ensure that all non-product software adhere to regulations and standards

Skills

Software Quality Engineering

Software Validation

Test Plans

Test Scripts

Software Requirements

Protocols

Non-Product Software

SDLC

Microbiology Lab

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

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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