TCP - Quality Testing Documentation Specialist at Abbott

North Chicago, Illinois, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, DiagnosticsIndustries

Requirements

Candidates must possess a Bachelor's Degree with 2-5 years of related work experience or an equivalent combination of education and experience. A working knowledge of business concepts, procedures, and practices within a quality system environment is required. Experience with LIMS systems for authoring test procedures and understanding the process is preferred. Knowledge of regulations and standards affecting IVDs and medical devices is also preferred, as is experience with IBM Cognos and/or Microsoft Power BI.

Responsibilities

The Quality Testing Documentation Specialist will implement and maintain the effectiveness of the quality system by creating, analyzing, and processing electronic Quality testing documents in compliance with QSR, ISO13485, and other applicable standards. This role involves initiating and verifying Document Change Requests, participating in project teams for document development, and creating/processing documents for new product development and on-market updates. The specialist will also assist in resolving complex issues, defining departmental procedures, providing technical assistance to internal customers, and building cross-functional relationships with departments such as R&D, Manufacturing, Quality Control, Regulatory Affairs, and Operations. The role requires the ability to work with a diverse international team and support multiple sites, as well as perform data mining activities.

Skills

Quality System

Documentation

QSR

ISO13485

Document Change Requests

Electronic Document Management

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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