Compliance and Audit Specialist

Contract Duration: Until 4/25/25 with the potential for extension

Work Hours: Full-time - 40 hours per week

Location: Minneapolis, MN – Onsite 3 days per week, remote for 2 days.

Target Pay Range: $60-$84.50/hr.

Education: Bachelor's degree required.

Experience: Minimum of 2 years of relevant experience in a similar role.

Key Requirements:

• Extensive experience with 21CFR820 , ISO13485 , and ISO14971 for Quality Management System requirements.
• Internal audit experience is preferred but not mandatory.
• Ability to work independently and effectively manage tasks with minimal supervision.
• Strong communication skills .
• Audit experience is preferred

Role Responsibilities:

• Coordinate and/or prepare for internal and external audits , ensuring compliance with regulatory standards, including FDA and equivalent global regulatory agencies.
• Interpret government regulations as they relate to products, processes, and procedures.
• Develop and enforce policies and procedures to ensure compliance with relevant regulations, meeting all regulatory reporting requirements.
• Investigate and resolve compliance issues from various stakeholders, including other departments, customers, and regulatory authorities.
• Analyze audit data, present findings to management, and support Corrective Action Plans (CAPAs).
• Assist in managing recalls and field actions as needed.
• Develop and implement programs to increase employee awareness and understanding of compliance policies.

Position Overview:

• Specialist Career Stream : Typically, an individual contributor responsible for specialized projects in a professional discipline. Works with other stakeholders to achieve project goals, may mentor colleagues, or direct the work of lower-level professionals. Most of the role involves delivering and overseeing projects, ensuring adherence to policies using specialized knowledge acquired through advanced education.

Key Differentiators:

• Autonomy: Works independently with general supervision on larger, moderately complex projects.
• Organizational Impact: Sets objectives for their area of work, contributing to the successful completion of projects and project milestones. May occasionally work on cross-functional assignments.
• Innovation & Complexity: Faces general problems, which may require a broader understanding of different job areas. Suggests adjustments or improvements to systems and processes to enhance effectiveness.
• Communication & Influence: Regular communication with internal stakeholders. External interactions tend to focus on information-sharing and problem-solving.
• Leadership & Talent Management: May mentor entry-level professionals and/or provide guidance to employees within the Support Career Stream.