Quality Manager at Abbott

Pleasanton, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Experience in defining and developing strategy for external and internal audits (Regulatory Agencies, Corporate, Notified Bodies, Certifications)
Knowledge of Quality Management System compliance to internal policies, applicable standards, and external regulatory requirements
Experience with oversight and administration of site CAPA system
Ability to utilize experience from audits, internal assessments, and cross-business community of practice to address compliance gaps
Leadership skills to influence cross-functional partners and peers on quality system requirements
Capability to analyze trends from various sources to proactively address regulatory, compliance, and quality issues
Experience participating in FDA inspections and leading internal/corporate audits, notified body audits, and external certification audits

Responsibilities

Provide leadership to maintain Quality Management System compliance for Abbott Heart Failure Pleasanton site
Oversee site’s compliance lifecycle and CAPA System
Lead site’s CAPA program and drive continuous improvements by providing strategic direction for robust CAPA investigations and implementation of resolutions while ensuring sustainability and effectivity
Serve as the primary interface with external regulatory bodies, manage internal and external inspections and overall audit strategies
Drive key readiness initiatives utilizing risk-based prioritization and mitigation to maintain an audit ready status
Evaluate and monitor the results of external and internal audits; report audit results to management and status/execution of corrective actions
Analyze trends from various sources and proactively address regulatory, compliance, and quality issues
Actively participate in FDA inspections and lead internal/corporate audits, notified body audits, and applicable external certification audits including any post-audit responses
Maintain data analysis requirements for applicable Quality System metrics and Quality Management Reviews (QMRs)

Skills

Quality Management Systems

Internal Audits

External Audits

Regulatory Compliance

Audit Strategy

QMS 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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