1+ months
2018-06-152018-11-11

Staff Compliance Specialist

Abbott
Plymouth, MN

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.

Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are collaborative, dynamic and progressive. We value people with new ideas who partner with others both internally and externally to take action and accomplish goals.

We are actively seeking an exceptional Staff level Compliance Specialist to serve as an authority and domain specialist for the compliance team with respect to observation tracking, auditing, regulations and standards, and the corporate quality system. You will conduct internal quality audits to assess company compliance to the requirements of the quality system, as well as FDA, ISO, MDD, CDR, MHLW, and other regulations applicable to the Abbott Quality System.

Are you ready to make a difference?

IMPACT THIS ROLE WILL HAVE ON ABBOTT:

  • Plan, perform, support and document QMS and EMS compliance audits
  • Have responsibility and department ownership for the tracking of corrective actions, including the electronic tracking 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 to other functional groups and facilities
  • Drive consistency of the teams methodologies and practices
  • Be responsible for the team's SharePoint sites
  • Build monthly reports for internal and external compliance observations
  • Identify and share industry trends through ongoing research
  • Maintain compliance files
  • Be a certified lead auditor
  • You will follow up on audit observations and actions
  • Support and maintain recall logs and files
  • Help develop tools to streamline audit consistency
  • Update compliance team documents, as requested
  • Passionately support and champion quality initiatives, goals, and metrics
  • Champion 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 agencies, Company policies, operating procedures, processes, and task assignments
  • Maintains positive and harmonious communications and collaboration with all levels of employees, customers, contractors, and vendors
  • Performs other related duties and responsibilities, on occasion, as assigned

    Your experience(s), education and knowledge will further expand Abbott's marketplace success:

    • Bachelor’s degree (incumbent exempt)
    • 10 years’ experience in the medical device industry and 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
    • Excellent writing skills are required
    • Able to excel in a highly matrixed and geographically diverse business environment
    • Ability 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 timely manner
    • Strong organizational and follow-up skills, as well as attention to detail
    • Ability to travel approximately 50-75%, including internationally
      Job Family: Operations Quality
      Division: CAHF Cardiac Arrhythmias & Heart Failure
      Travel: Yes, 50 % of the Time
      Medical Surveillance: No
      Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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Staff Compliance Specialist

Abbott
Plymouth, MN

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