Senior Manager Quality at Abbott

Des Plaines, Illinois, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Diagnostics, Medical DevicesIndustries

Requirements

Strong leadership and guidance skills for managing the quality department
Expertise in Nonconformance/CAPA process management and oversight, including Material Review Board, CAPA Review Board, process metrics, quality record approvals
Experience partnering with cross-functional areas on strategic initiatives
Ability to lead Global QA initiatives to implement quality systems/processes across the organization and Division
Knowledge of developing goals, objectives, procedures, policies, and systems aligned with company goals, mission, vision, and FDA/ISO regulations
Proficiency in ensuring manufacturing quality system requirements are effectively established and maintained
Skills in reporting on quality system performance to management
Expertise in overseeing and executing Nonconformance and CAPA subsystems, including MRB and CAPA Review Board activities, material control processes, investigations, root cause analysis, resolution plans, and effectiveness checks
Proficiency in applying Statistical Process Control (SPC) and process monitoring techniques
Ability to utilize statistical analysis to interpret data, identify trends, and drive continuous improvement
Experience implementing and maintaining risk management strategies for regulatory compliance
Strong critical thinking and problem-solving skills
Frequent interaction with internal and external management and senior-level representatives on projects, operational decisions, scheduling, and contractual clarifications
Ability to provide direction and guidance to exempt specialists

Responsibilities

Maintain high quality levels on all products while achieving high efficiency
Lead the quality department with overall responsibility for quality systems
Oversee and execute Nonconformance and CAPA subsystems, including Material Review Board (MRB) and CAPA Review Board activities, material control processes, investigations, root cause analysis, development and implementation of resolution plans, and effectiveness checks
Apply Statistical Process Control (SPC) and process monitoring techniques to ensure product and process stability
Utilize statistical analysis to interpret data, identify trends, and drive continuous improvement initiatives
Implement and maintain risk management strategies to mitigate potential issues and ensure compliance with regulatory standards
Ensure the overall quality of products and services meets internal and external customer requirements
Report on the performance of the quality system to management with executive responsibility for review
Assure manufacturing quality system requirements are effectively established and maintained
Lead Global QA initiatives to implement quality systems/processes across the organization and Division for quality improvements, cross-plant consistency, and regulatory compliance
Develop goals, objectives, procedures, policies, and systems in line with company goals, objectives, mission, vision, and FDA/ISO regulations

Skills

Quality Management

Leadership

Molecular Diagnostics

Regulatory Compliance

Healthcare Quality

Product Quality

Efficiency Optimization

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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