Quality Manager at Abbott

Pleasanton, California, United States

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Not SpecifiedCompensation

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
Ability to act as a key influential leader for Audit Readiness program and drive quality system improvements
Expertise in oversight and administration of site CAPA system
Experience with cross-functional collaboration to ensure understanding of quality system requirements
Proficiency in utilizing audit and assessment experience to address compliance gaps
Strong leadership skills for maintaining QMS compliance
Capability to serve as primary interface with external regulatory bodies
Skills in risk-based prioritization and mitigation for audit readiness
Ability to evaluate, monitor, and report audit results and corrective actions
Experience analyzing trends from audits and assessments to address issues
Participation in FDA inspections and leading various audits
Proficiency in data analysis for Quality System metrics and Quality Management Reviews (QMRs)

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, 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 post-audit responses
Maintain data analysis requirements for applicable Quality System metrics and Quality Management Reviews (QMRs)
Define and develop strategy for external and internal audits to ensure site compliance and audit readiness
Ensure cross-functional partners understand quality system requirements and their impact on product quality and regulatory compliance
Utilize experience from audits, assessments, and cross-business practices to proactively address compliance gaps
Act as a key influential leader responsible for the overall Audit Readiness program and driving initiatives to improve quality systems and organizational compliance

Skills

Quality Management Systems

QMS Compliance

Internal Audits

External Audits

Regulatory Compliance

Audit Strategy

Quality Assurance

Regulatory Standards

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