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Sr Compliance/Audit Spec

Saint Paul, MN 55112

Posted: 09/19/2023 Employment Type: Contract Job Category: Engineering Job Number: 582172 Is job remote?: No Country: United States

Job Description

Top 3 things the manager is looking for in a candidates experience: 
  1. Audit Experience with ISO 13485:2016
  2. Ability to work in a team setting and quick learner
  3. Organization

Top 3 Tasks or Responsibilities in scope for this role:
  1. Audit Coordination
  2. Audit Support and preparation of documentation for audit
  3. Audit communication to Leadership

Responsibilities may include the following and other duties may be assigned.
  • • Coordinates and/or completes internal/external risk assessments and/or audits and compliance in accordance with regulatory standards, which may include US and/or international regulatory agencies / authorities.
  • • Manages and oversees internal audit activities, which may include conducting and/or overseeing audits, investigations, and/ or interviews; and preparing corresponding reports and documents.
  • • Interprets and implements applicable regulations as they apply to products, processes, practices and procedures.
  • • May counsel stakeholders about these requirements as necessary.
  • • Ensures compliance with internal and external regulatory agencies, which may include investigating and resolving compliance violations, questions, or concerns.
  • • Analyzes audit data and presents findings to management and/or regulatory bodies in support of Corrective Action Plans, which may include coaching business partners on compliance gaps, data, and/or resulting corrective actions.
  • • Develops and implements programs, communications, and/or training designed to increase employee awareness and knowledge of compliance policies and/or processes.
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