Veterans at Abbott
Abbott Staff Quality Auditor in Alameda, California
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
This role does Supporting / leading assigned internal audit and external audit processes.
Supporting / leading the compliance gap management activities including regulatory /standards tracking and other compliance management activities.
Lead/support assigned internal/clinical audits to maintain timely closure of the audit cycles
Support Audit Readiness activities for external audits including training staff /guidance in preparation of external audits.
Support compliance gap management activities e.g. compliance risk management- Identifies risks to the business and resolutions to address compliance gaps.
Strategize and prioritize the compliance gaps and track them to the closure.
Provides guidance to the subject matter experts (SMEs) in closing the compliance gaps.
Track regulations and industry standards revisions. Evaluate and communicate the impact of these revisions with the related departments and follow up compliance to these revisions.
ares/ reviews/analyses the metrics data.
Promotes awareness and understanding of quality & compliance within the division. Provide training to the division to increase compliance awareness.
Participate/Manage the compliance initiatives and other assigned projects.
Bachelors Degree in Technical Field, Science, or Engineering. Minimum 8 years Medical Device or Pharma. Minimum 5 years Quality Assurance, Internal Auditing, Quality Compliance Management or related experience. Lead Auditor Certificate desired.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org