Staff Compliance Specialist

11 - 15 years experience  • 

Salary depends on experience
Posted on 05/21/18
Plano, TX
11 - 15 years experience
Salary depends on experience
Posted on 05/21/18

JOB DESCRIPTION:

We are seeking an experienced, high caliber Staff Compliance Specialist. This role will serve as experts for the compliance team with respect to observation tracking, auditing, regulations and standards and the corporate 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.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 team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.Impact this role will have on Abbott:

  • Plan, perform,support and document QMS and EMS complianceaudits
    • 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
  • Performs other related duties and responsibilities, on occasion, as assigned

 Your experience(s), education and knowledge will further expand St. Jude Medical’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
  • 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
  • Ability to maintain regular and predictable attendance

 Your preferred qualifications and education:

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

30059458

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