Seeking an experienced professional with extensive knowledge of 21 CFR 820, ISO 13485, and ISO 14971 Quality Management System requirements to support audits and regulatory compliance activities.

Job Requirements Extensive experience with 21 CFR 820, ISO 13485, and ISO 14971 for Quality Management Systems. Internal audit experience preferred. Ability to work independently. On-site presence at Rice Creek, Fridley, MN, three days per week, with two days remote. Preferred Skills Audit experience. Familiarity with FDA and international regulatory standards. Job Responsibilities Coordinate and/or prepare internal and external audits for compliance with regulatory standards, including FDA and international equivalents. Interpret government regulations as they apply to products, processes, and procedures. Implement policies and procedures to ensure compliance with relevant statutes and regulations. Investigate and resolve compliance issues, complaints, or problems received from various stakeholders. Analyze audit data, present findings to management, and support the development of Corrective Action Plans. Provide coaching to business partners on compliance matters. Assist in managing recalls and field actions. Develop and implement programs to increase employee awareness and knowledge of compliance policies.

Pay Details: $54.00 to $72.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
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