CAPA Specialist - Processing

Sturgis, Michigan, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, NutritionIndustries

Requirements

Candidates should possess a Bachelor’s degree in a related field, and demonstrate at least 3 years of experience in CAPA systems, with a strong understanding of quality systems and regulatory requirements. Experience with nonconformity investigations and root cause analysis is essential, along with proficiency in using CAPA systems and investigational tools.

Responsibilities

The CAPA Specialist will progress investigations through the CAPA system, working with other functional areas to determine root causes and ensure CAPA plans address these issues. They will monitor the implementation of corrective and preventative actions, conduct effectiveness checks, and maintain CAPA system records to ensure audit readiness. The role involves facilitating the investigation process, supporting a multifunctional team, and ensuring compliance with corporate and regulatory requirements, ultimately contributing to the effectiveness of the CAPA system and the overall quality system.

Skills

CAPA system

Investigation

Root cause analysis

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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