Quality & Regulatory Analyst — FDA-Regulated Manufacturing

Mayo Clinic; Rochester (MN); On-site; USD 78,270 - 117,312; Full time

Benefits offered by this job

Medical plan options

Dental coverage or reimbursement

Vision coverage

HSA and FSAs

Retirement package

Job summary

Mayo Clinic in Rochester, MN seeks a Quality Analyst, FDA Regulated Manufacturing, to ensure regulatory compliance in product manufacturing. You will lead QMS implementation and partner across departments to integrate quality into operations.

The role requires a bachelor’s in a science field and at least five years in quality, with knowledge of FDA GMPs, ISO, and related regulations. ASQ certification encouraged; visa sponsorship not available.

Qualifications

• Bachelor’s degree in science and 5+ years in a quality-related field.
• Knowledge of laws, regulations and guidance related to FDA regulated industries (biologics, pharmaceuticals).
• Experience with FDA GMPs, ISO certification and quality systems (SOPs, audits, documentation).
• Excellent written and verbal communication and strong organizational skills.

Responsibilities

• Implement quality and regulatory compliance for product manufacturing activities.
• Lead the Quality Management System (QMS) and ensure quality integrated into operations.
• Collaborate across departments to identify and mitigate regulatory and compliance risk.

Skills

Quality assurance

Regulatory compliance

QA leadership

Analytical thinking

Written and verbal communication

Education

Bachelor's degree in science (e.g., biology, chemistry)

Tools

Quality Management System (QMS)

Job description

Mayo Clinic in Rochester, MN seeks a Quality Analyst, FDA Regulated Manufacturing, to ensure regulatory compliance in product manufacturing. You will lead QMS implementation and partner across departments to integrate quality into operations.

The role requires a bachelor’s in a science field and at least five years in quality, with knowledge of FDA GMPs, ISO, and related regulations. ASQ certification encouraged; visa sponsorship not available.