Compliance/Audit Specialist (3-6 month contract // Minneapolis, MN):
This role is hybrid, 3 days on site per week
HM's Top Needs:
- Extensive experience with 21CFR820, ISO13485 and ISO14971 for Quality Management System Requirements
- Internal Audit experience preferred, but not required
- Ability to work independently with strong communication skills
- Audit experience preferred but not required
Duties:
- Performs the coordination and/or preparation of internal and external audits and compliance in accordance with regulatory standards (includes FDA and its equivalents outside the US as well as other government regulatory agencies / authorities).
- Interprets government regulations as they apply to products, processes, practices and procedures.
- Implements policies and procedures to ensure that these are in compliance with the appropriate statutes and regulations and ensures that regulatory reporting requirements are met.
- Investigates and resolves compliance problems, questions, or complaints received from other units of the company, customers, government regulatory agencies, etc.
- Analyze audit data and present findings to management, support Corrective Action Plans, and provide coaching to business partners.
- Assist in managing recalls and field actions.
- Develop and implement programs designed to increase employee awareness and knowledge of compliance policies.