Associate Director, Complaint Handling at Abbott

Alameda, California, 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 Devices, Nutritionals, PharmaceuticalsIndustries

Requirements

Serves as process owner and subject matter expert for Complaint Handling and representative for the Formally Designated Unit (FDU)
Acts as primary contact for complaint handling process during audits, inspections, and assessments by global regulatory agencies
Works closely with Commercial Teams and Commercial Senior Management to ensure worldwide Customer Service follows global regulations and divisional procedures for call registration and complaint handling
Develops strategies for the Commercial Organization related to complaint handling
Provides direct and indirect supervision to professional and labor staff, including personnel development and performance assessment
Ensures compliance with global regulations, divisional, and Abbott policies and procedures, including employee training
Interacts with division's Senior and Executive management on complaints handling and product performance issues
Anticipates, recognizes, communicates, and manages quality issues, collaborating with cross-functional areas to resolve them
Based in Abbott Diabetes Care in Alameda, CA, with onsite presence Monday-Friday

Responsibilities

Implements and maintains the effectiveness of the quality system
Identifies and recruits staffing/resources to support complaint handling activities and on-market support for multiple critical product lines
Identifies and implements organizational structure to achieve business objectives and QA compliance within complaint handling
Ensures complaints are evaluated against criteria for potentially reportable events and elevated to the medical events group to meet worldwide reporting requirements
Champions and actively participates in development/improvements of complaint handling processes and procedures
Works effectively with Customer Service, R&D, and other internal/external organizations to coordinate and facilitate improvements in complaint handling processes
Works closely with Complaint Investigation, Supplier QA, and Operations teams to ensure exception reports and corrective/preventive actions

Skills

Complaint Handling

Regulatory Compliance

Audit Management

Process Ownership

Customer Service

Global Regulations

Quality Assurance

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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