Manager, Quality Manager - CAPA at Abbott

North Chicago, Illinois, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Working knowledge of global regulations and industry standards, especially related to complaint management, recalls, and medical device reporting
Knowledge of related Quality System elements, e.g., Vigilance Reporting, Risk Management, Nonconformances & CAPA, etc
Established management skills to lead global committees and teams
Ability to act as corporate liaison and subject matter expert in complaints management, product actions, and medical device reporting
Current knowledge of regulatory requirements, best practices, and regulatory agency expectations
Experience managing multiple global projects, particularly in Complaint Management, Product Actions, and Adverse Event Reporting
Ability to handle confidential information across project lifecycles

Responsibilities

Provide corporate-level leadership and guidance for Quality Systems matters related to complaint management, medical device reporting/vigilance, and product actions (corrections and removals)
Support other Abbott Quality System elements related to post-market surveillance
Provide global support to Abbott Businesses/Divisions, including subject matter expertise, training, and consultation on regulatory and compliance strategy and application
Lead global committees and teams to achieve quality, regulatory compliance, and business objectives
Act as the corporate liaison to Abbott Businesses/Divisions and provide expert support in complaints management, product actions, and medical device reporting
Remain current on regulatory requirements, best practices, and regulatory agency expectations to drive updates in corporate policies and procedures
Participate in industry groups related to complaints management, product actions, and medical device reporting
Improve the effectiveness of Abbott’s Quality Systems through monitoring, trending, and analyzing quality data and industry intelligence
Act as a change agent for incorporating best practices through business support activities such as remediation, training, and coaching
Manage multiple global projects, particularly in Complaint Management and Product Actions, with active participation in global Adverse Event Reporting projects

Skills

CAPA

Complaint Management

Vigilance

Medical Device Reporting

Post Market Surveillance

Quality Systems

Product Actions

Regulatory Compliance

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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