Abbott Senior Quality Compliance Specialist in Minneapolis, Minnesota

At Abbott, we're committed to helping you live your 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, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.

JOB DESCRIPTION:

Job Duties:

  • Plan, perform, support and document QMS and EMS compliance audits. These audits must be tracked to standards and regulations.

  • Manage the tracking of the corrective actions.

  • Support checklist maintenance and updates.

  • Contribute and support internal and external team Sharepoint sites.

  • 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.

  • Assist and support customer and external audits, as requested.

  • 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.

  • Perform specialty audits, as requested by management.

  • Mentor compliance and quality team members:

  • Divisional compliance team practices and expectations

  • Audit conduct

  • Checklist system

  • Department tools

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

Qualifications :

  • Bachelor's degree or equivalent work experience

  • 5+ years of experience in the systems quality discipline with extensive backend, integration project testing

  • 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 10%, including internationally.

  • Ability to maintain regular and predictable attendance.

JOB FAMILY:

Operations Quality

DIVISION:

ASJM Abbott St. Jude Medical

LOCATION:

United States > Minnesota : 5050 Nathan Lane N.

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 15 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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