Quality Auditor

Danaher • Fargo, ND

5d • Onsite

About The Position

The Quality Auditor is responsible for ensuring the integrity and effectiveness of Aldevron’s Quality Management System by planning and executing internal and external audits that drive continuous compliance and operational excellence. This role safeguards product quality and regulatory readiness by identifying process gaps, validating adherence to cGMP and global regulatory standards, and partnering with cross‑functional teams to implement sustainable corrective actions.
This position reports to the Manager, Quality Audits and is part of the Quality Systems team located in Fargo, ND and will be an on-site role.

Requirements

• Bachelor’s Degree required; ASQ Certified Quality Auditor preferred.
• Experience in a cGMP environment and in a quality role, with a preference for experience in Compliance, Supplier Management, and Regulatory Affairs.
• Strong knowledge of quality systems, including required expertise in ICH Q10 and 21 CFR Part 210/211; additional experience with cGMP, ISO 13485, FDA, and EU regulatory standards is preferred.
• Experience working with and effectively communicating with the FDA and other regulatory agencies.
• Ability to travel – occasional domestic travel for audits, etc.

Nice To Haves

• ASQ Certified Quality Auditor preferred.
• additional experience with cGMP, ISO 13485, FDA, and EU regulatory standards is preferred.
• preference for experience in Compliance, Supplier Management, and Regulatory Affairs.

Responsibilities

• Plan, coordinate, and conduct internal and external QMS and product-focused audits, ensuring compliance and effectiveness by following internal SOPs and relevant auditing standards.
• Develop comprehensive audit checklists, prepare and review audit reports, and follow up on findings, coordinating with technical specialists to ensure complete records and effective resolution.
• Maintain supplier qualifications, oversee supplier notifications, optimize standard procedures for cGMP components and materials, and monitor domestic and international regulations to ensure compliance and update relevant personnel accordingly.

Benefits

• Aldevron, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
• This job is also eligible for bonus/incentive pay.
• We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level