Test Control Procedure (TCP) Specialist at Abbott

Des Plaines, Illinois, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Diagnostics, Medical DevicesIndustries

Requirements

Bachelor's Degree or an equivalent combination of education and work experience
2-5 years of related work experience with a good understanding of specified functional area
Working knowledge and application of business concepts, procedures, and practices
Ability to perform in a quality system environment, where failure to adequately perform tasks can result in noncompliance with governmental regulations
Ability to work on problems of moderate scope where analysis of situations or data requires a review of identifiable factors
Exercises judgment within defined procedures and practices to determine appropriate action
Has a general knowledge of applicable regulations and standards (e.g., QSR, ISO13485)
Ability to work with a diverse and dynamic international team providing support for multiple sites

Responsibilities

Implementing and maintaining the effectiveness of the quality system
Creating, analyzing, and processing electronic Quality testing documents in compliance with QSR, ISO13485, and other applicable standards
Initiating Document Change Requests and associated packages relating to electronic documents and verifying for correctness of the submitted Change in alignment with testing site requirements
Participating in project teams to further develop efficient and effective electronic Quality testing and ancillary documents
Creating, analyzing, and processing electronic Quality testing and ancillary documents for new product development and on-market updates
Assisting in resolving complex issues and providing judgment and recommendations to the manager
Assisting in defining and documenting departmental procedures and standards to meet Regulatory and Division requirements
Providing customers (internal) with technical assistance in the development and execution of the electronic Quality testing document
Building and maintaining successful cross-functional relationships with internal departments such as R&D, Manufacturing, Quality Control, Regulatory Affairs, and Operations
Performing and supporting data mining activities

Skills

Test Control Procedure

TCP

Quality Control

Document Management

Molecular Diagnostics

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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