Quality Assurance Specialist III

Mesa Labs; Bozeman (MT); On-site; USD 51,000 - 64,000; Full time

Benefits offered by this job

Bonus opportunity

Health Insurance

401(k) plan with match

Paid time off

Job summary

Mesa Labs in Bozeman, MT is seeking a Quality Assurance Specialist III to lead QA and compliance initiatives, ensuring products and processes meet regulatory standards. You will guide audits, implement quality strategies, and mentor teams across departments.

The role emphasizes cross‑functional collaboration, risk management, and continuous improvement within a fast‑paced environment. A strong background in FDA/ISO/GMP standards is essential.

Qualifications

• Bachelor's degree in Quality Management, Engineering, Life Science, or a related field.
• Minimum of 5 years of experience in Quality Assurance or related field.
• Experience leading audits and quality programs.

Responsibilities

• Lead quality assurance and compliance strategies.
• Oversee complex audits of products, processes and systems.
• Serve as SME on regulatory requirements (FDA, ISO, GMP).
• Identify and drive improvements in quality and compliance processes.
• Develop corrective and preventive action plans for non‑compliance.
• Provide leadership and training to QA teams.
• Prepare reports on quality metrics and compliance status.
• Collaborate with R&D, Manufacturing and Supply Chain.

Skills

Quality assurance

Regulatory compliance

Leadership

Analytical skills

Communication

Project management

Education

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

Job description

Are you looking for an opportunity to make a difference? At Mesa Labs we’re passionate about protecting the vulnerable by enabling scientific breakthroughs, ensuring product integrity, increasing patient and worker safety, and improving quality of life around the world.

At Mesa Labs we offer competitive wages, including bonus opportunity, and a comprehensive benefits package.

Base Compensation Range: $24.64/hr - $30.77/hr
This position is eligible for an annual 10% bonus opportunity in addition to the base salary

Outstanding Benefits and Perks:
We are proud to offer a variety of benefits that meet the diverse needs of our employees:

• Eligible for benefits the first day of the month after you start
• Tiered Medical, Dental and Vision Insurance options
• Health savings (HSA), healthcare & dependent care flexible spending (FSA) accounts
• Company paid short term and long-term disability (unless covered by a state disability plan)
• Company paid life insurance and AD&D
• 3 weeks of accrued vacation time; accruals begin on Day 1
• Paid sick leave of 48 hours per calendar year
• Eligible employees may receive four (4) weeks paid Care Giver leave after 1 year of service or in accordance with state leave laws
• 401(k) plan that provides a 4% Safe Harbor company match on a 4% employee contribution that begins on Day 1
• Employee Wellness and Financial Assistance Resources through Cigna and NY Life
• Nine (9) paid company holidays per year
• Overtime opportunities
  

Sterilization and Disinfection Control division manufactures and sells biological and chemical indicators that assess the effectiveness of sterilization and disinfection processes for pharmaceutical, healthcare, and dental industries.

Job Summary

The Quality Assurance Specialist III is responsible for leading and overseeing quality assurance and compliance activities within the Company. Develop and implement quality assurance strategies, ensuring adherence to regulatory standards, and providing expert guidance on complex compliance issues.

Duties/Responsibilities

• Leadership and Strategy:
  • Develop and implement comprehensive quality assurance and compliance strategies to ensure that products, services, and processes meet or exceed regulatory and quality standards.
• Advanced Auditing:
  • Lead complex audits of products, processes, and systems to assess compliance with internal standards and regulatory requirements.
  • Oversee audit teams and manage audit schedules.
• Regulatory Affairs:
  • Serve as the subject matter expert on regulatory requirements and industry standards. Ensure that the company remains compliant with all relevant regulations (e.g., FDA, ISO, GMP) and anticipate changes in regulatory landscapes.
• Process Optimization:
  • Identify and drive improvements in quality and compliance processes.
  • Develop and implement strategic initiatives to enhance overall quality and operational efficiency.
• Evaluate and mitigate quality and compliance risks.
• Develop and oversee corrective and preventive action plans to address non-compliance and quality issues.
• Training and Mentorship:
  • Provide leadership and training to quality assurance teams and other departments.
  • Mentor junior staff and foster a culture of continuous improvement and compliance excellence.
• Reporting and Communication:
  • Prepare and present detailed reports on quality metrics, audit findings, compliance status, and strategic recommendations to senior management and regulatory bodies.
• Cross-Functional Collaboration:
  • Collaborate with other departments (e.g., R&D, Manufacturing, Supply Chain) to integrate quality and compliance requirements into all stages of product development and delivery.

Experience/Education

• Bachelor's degree in Quality Management, Engineering, Life Science, or a related field.
• Minimum of 5 years of experience in Quality Assurance or related field.

Knowledge and Skillsets Required

• Deep knowledge of quality assurance principles, regulatory requirements, and industry standards.
• Proven track record of managing complex compliance projects and leading teams.
• Strong analytical and problem-solving skills.
• Excellent leadership, communication, and interpersonal skills.
• Ability to manage multiple high-priority projects simultaneously.
• Capacity to work independently and as part of a leadership team.
• Ability to navigate and influence in a fast-paced and dynamic environment.

Physical Demands:

• Sitting: Often for extended periods at desks or meetings.
• Standing or walking: Occasionally for meetings or office tasks.
• Using computers: Typing and using office equipment.
• Lifting: Light, less than 10 pounds.
• Repetitive motions: Frequent use of keyboard and mouse.

Environmental Conditions:

• Workspace: Climate control (air conditioning or heating) to ensure comfort.
• Lighting: Adjustable lighting to reduce eye strain.
• Noise Levels: The noise level is moderate, with occasional interruptions from phone calls and conversations. Use non-canceling headphones if necessary.
• Ergonomics: Workstations with desk and adjustable chairs to support good postures.
• Ventilation: Good ventilation to ensure a comfortable working environment, though this can vary depending on the building.

Mesa Labs is an Equal Employment Opportunity Employer.

Mesa Labs prohibits unlawful discrimination and harassment against applicants or employees based on age, race, sex, color, religion, creed, national origin or ancestry, disability, military status, sexual orientation, or any other status protected by applicable state or local law. Please note that Mesa Labs conducts criminal background checks upon offer acceptance.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.