Staff Quality Auditor at Abbott

Alameda, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, DiagnosticsIndustries

Requirements

Bachelor’s degree in a scientific, engineering, or quality-related field (equivalent combination of education and minimum of 10 years of work experience will be considered)
Minimum 10 years of experience in the medical device industry
Minimum 8 years of auditing experience per ISO and/or FDA standards
Knowledge of MDD, CMDR, MHLW, TGA, ANVISA, or other geographic regulations
Lead Auditor Certification for ISO 13485 or 9001:2000
Proficient writing skills

Responsibilities

Plan, perform, support, and document QMS and EMS compliance audits to standards and regulations
Manage the tracking of corrective actions, including the electronic system
Perform interpretation and analyses of international standards and regulations and document gaps, where appropriate
Review and approve checklist changes and amendments
Serve as a liaison for the compliance team to other functional groups and facilities
Drive consistency of compliance team practices
Manage internal and external team SharePoint sites
Create monthly reports for internal and external compliance observations
Identify and share industry trends through ongoing research
Maintain compliance files
Follow up on internal and external audit observations and actions
Support and maintain recall log and files
Develop tools to streamline audit consistency
Update compliance team documents, as requested
Support quality initiatives, goals, and metrics
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

Skills

Quality Auditing

QMS

EMS

FDA Regulations

ISO Standards

MDD

CDR

MHLW

Compliance

Observation Tracking

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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