Senior QA & Regulatory Compliance Leader

Mesa Laboratories, Inc.; Bozeman (MT); On-site; USD 34,000 - 42,000; Full time

Benefits offered by this job

Bonus opportunity

Competitive wages

401(k) with company match

Paid time off (3 weeks)

Paid sick leave (48 hours/year)

Life Insurance & AD&D

Health, Dental, Vision insurance

Job summary

Mesa Laboratories, Inc. in Bozeman, MT is seeking a Quality Assurance Specialist III to lead QA and compliance initiatives across products and processes.

You will drive strategic QA programs, oversee complex audits, and partner with R&D, Manufacturing, and Supply Chain to ensure FDA/ISO/GMP compliance. The role requires at least 5 years in QA, a strong regulatory background, and a proven ability to mentor teams in a fast-paced environment.

Qualifications

• Bachelor's degree in Quality Management, Engineering, Life Science, or related field.
• Minimum of 5 years in Quality Assurance or related field.
• Knowledge of FDA, ISO, GMP standards.

Responsibilities

• Lead quality assurance and compliance strategies.
• Oversee audits of products, processes, and systems.
• Ensure regulatory compliance with FDA, ISO, GMP.
• Coach and mentor QA teams.
• Report quality metrics to senior management.
• Collaborate with R&D, Manufacturing, and Supply Chain.

Skills

Quality assurance

Regulatory knowledge

Audit leadership

Risk management

Regulatory standards

Cross-functional collaboration

Communication

Problem solving

Education

Bachelor's degree in Quality Management, Engineering, Life Science, or related field

Job description

Mesa Laboratories, Inc. in Bozeman, MT is seeking a Quality Assurance Specialist III to lead QA and compliance initiatives across products and processes.

You will drive strategic QA programs, oversee complex audits, and partner with R&D, Manufacturing, and Supply Chain to ensure FDA/ISO/GMP compliance. The role requires at least 5 years in QA, a strong regulatory background, and a proven ability to mentor teams in a fast-paced environment.