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 critical thinking and problem-solving skills to support decision-making and process improvements
Ability to apply Statistical Process Control (SPC) and process monitoring techniques
Proficiency in statistical analysis to interpret data, identify trends, and drive continuous improvement
Experience with risk management strategies to mitigate issues and ensure regulatory compliance
Capability to interact frequently with internal and external management and senior-level representatives on projects, operational decisions, scheduling, and contractual clarifications
Leadership skills to provide direction and guidance to exempt specialists

Responsibilities

Provide leadership and guidance for the quality department to maintain high quality levels on all products while achieving high efficiency
Oversee and execute the 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
Ensure manufacturing quality system requirements are effectively established and maintained, and report on quality system performance to management
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 aligned with company goals, mission, vision, and FDA/ISO regulations
Assure overall quality of products and services meets internal and external customer requirements
Partner with cross-functional areas on strategic initiatives, including process metrics, quality record approvals, and Nonconformance/CAPA process management and oversight

Skills

Key technologies and capabilities for this role

Quality ManagementLeadershipMolecular DiagnosticsRegulatory ComplianceHealthcare QualityProduct QualityQuality AssuranceTeam LeadershipProcess Improvement

Questions & Answers

Common questions about this position

What benefits does Abbott offer?

Abbott provides free medical coverage in the Health Investment Plan (HIP) PPO medical plan, an excellent retirement savings plan with high employer contribution, tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit for earning a bachelor’s degree.

Is this position remote or onsite?

The position is located in Des Plaines, Illinois, indicating it is an onsite role.

What are the main responsibilities for this role?

The role involves providing leadership for the quality department, overseeing Nonconformance/CAPA processes, leading Global QA initiatives, developing quality goals and policies aligned with FDA/ISO regulations, and ensuring manufacturing quality system requirements are met.

What is the company culture like at Abbott?

Abbott emphasizes doing work that matters, personal growth and learning, caring for yourself and family, being your true self, career development in an international company, and is recognized as a great place to work for diversity, working mothers, female executives, and scientists.

What makes a strong candidate for this Senior Manager Quality role?

A strong candidate will have leadership experience in quality management, expertise in Nonconformance/CAPA processes, knowledge of FDA/ISO regulations, and the ability to lead global QA initiatives and partner cross-functionally.

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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