Abbott · 14 hours ago
Staff Quality Auditor
Alameda, CA
Full-time
Onsite
Senior Level, Lead/Staff
$114K/yr - $228K/yr
10+ years expAbbott is a global healthcare leader that helps people live more fully at all stages of life. The Staff Quality Auditor role focuses on conducting internal quality audits to ensure compliance with various regulations and standards, while also managing corrective actions and supporting quality initiatives.
BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical
Responsibilities
Plan, perform, support and document QMS and EMS compliance audits. These audits to standards and regulations
Manage the tracking of the 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 report for internal and external compliance observations
Identify and share industry trends through ongoing research
Maintain compliance files
Be a certified lead auditor
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
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
Qualification
Required
Bachelor's degree in a scientific, engineering, or quality-related field
Equivalent combination of education and mins of 10 yrs of work experience will be considered
Min 10 years of experience in the medical device industry
Min 8 years auditing 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 required
Preferred
Experience working in a broader enterprise/cross-division business unit model preferred
Ability to work in a highly matrixed and geographically diverse business environment
Ability to work within a team and as an individual contributor in a fast-paced, changing environment
Ability to leverage and/or engage others to accomplish projects
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
Multitasks, prioritizes and meets deadlines in timely manner
Strong organizational and follow-up skills, as well as attention to detail
Ability to travel approximately 50-75%, including internationally
Benefits
Free medical coverage for employees via the Health Investment Plan (HIP) PPO
An excellent retirement savings plan with high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
Company
Abbott
Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.79M2011-03-15Post Ipo Debt· $0.1M
2009-03-16Post Ipo Debt· $6.69M
1980-12-12IPO
Leadership Team
Robert Ford
President & Chief Executive Officer
Mike Peterson
Senior Vice President
Recent News
2026-01-07
Company data provided by crunchbase