Job Details

Staff Quality Auditor

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 114,000 colleagues serve people in more than 160 countries.

The Opportunity: This role for the Staff Quality Auditor will serve as experts for the compliance team with respect to observation tracking, auditing, regulations and standards and the division quality system. This role will conduct internal quality audits to assess compliance to the requirements of the quality system, as well as FDA, ISO, MDD, CDR, MHLW, and other regulations applicable to the CATD Quality System. This position will be based out of our Abbott Diabetes Care in Alameda, CA and the individual will be expected to be onsite Monday-Friday.

What You'll Work On:

• Plan, perform, support and document QMS and EMS compliance audits.
• 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.

Required Qualifications:

• 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 Qualifications:

• 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.