ABBOTT LABORATORIES Quality Analyst II Salary in the United States

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.

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

JOB DUTIES: 

• Plan, perform, support and document QMS (Quality Management Systems) compliance audits. Track audits to standards and regulations.

• Support the setting of the audit schedule, maintenance of the schedule, and/or update it as necessary

• Lead the tracking of the corrective actions

• Conduct CAPA investigation and able to judge the quality of investigations based on technical knowledge, tracks issues through to closure including reviewing the corrective action taken.

• Updates and maintains audit performance metrics. Present results to management

• Support checklist maintenance and updates.

• Support and contribute with the maintenance and updates to internal and external team SharePoint sites and software tools.

• Maintain compliance files.

• Monitors compliance of company policies and procedures with external standards and regulations (e.g. compliance with FDA, BSI, EEO regulations, etc.).

• Support external audits.  Support and/or participant during external audits.

• Responsible for follow up on audit observations and actions.

• Identifies and implements data analysis, systems evaluation, and product assessment to ensure system conformance and ensure finished products meet standards and specifications; implement and drive changes where needed

• 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) and other regulatory requirements.

• Aligns 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.

• Perform audits, as requested by management.

• Performs other related duties and responsibilities, on occasion, as assigned to you.

QUALIFICATIONS:

• Bachelor's degree or equivalent work experience

• 3+ years of experience in the systems quality discipline with extensive back-end, integration project testing

• Lead auditor certification for ISO13485 or 9001 preferred

• Advanced computer skills, including gap analyses and report writing skills

• Experience working in a broader enterprise/cross-division business unit model preferred.

• Ability to work in a highly matrix and geographically diverse business environment.

• Able to work within a team and as an individual contributor in a dynamic, changing environment.

• Ability to influence 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 a timely manner.

• Strong organizational and follow-up skills, as well as attention to detail.

• Ability to travel approximately 30%, including internationally.

• Statistical tool analysis knowledge preferred

• Microsoft Office Suite proficiency preferred (Word, Excel, Power Point, Visio, Project)