Associate Quality Auditor

Mesa Labs, Inc.; Bozeman (MT); On-site; USD 37,000 - 47,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Health Savings Account (HSA)

Life Insurance

Short/Long-term Disability

Vacation Time

Sick Leave

Caregiver Leave

401(k) with match

Wellness Resources

Holidays

Job summary

Mesa Labs, Inc. is seeking an Associate Quality Auditor to plan, conduct, and report on internal quality audits across manufacturing and process environments. You will identify compliance gaps, assess risk, and support continuous improvement initiatives.

With supervision, you will apply judgment to ensure adherence to GLP, GMP, ISO, and Six Sigma principles, while collaborating across teams to strengthen quality systems.

Qualifications

• Bachelor’s degree in Quality, Engineering, Life Sciences, or a related technical field required.
• 0-2 years of experience in quality assurance, quality auditing, or regulated manufacturing environments.

Responsibilities

• Plan, schedule, and conduct internal quality audits of manufacturing, production, and process controls.
• Develop audit plans, checklists, and sampling strategies based on standards, history, and risk.
• Execute audits to assess compliance with procedures and regulations (GLP, GMP, ISO).
• Prepare audit reports detailing observations and risk assessments and communicate results to stakeholders.
• Support external audits and act as a point of contact during on-site activities.

Skills

Audit Planning

Internal Audits

Regulatory Standards

CAPA

Quality Documentation

Education

Bachelor's degree in Quality/Engineering/Life Sciences

Tools

eQMS

Job description

Are you looking for an opportunity to make a difference? At Mesa Labswe’repassionate 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 bonusopportunity, and a comprehensive benefits package.

Base CompensationRange: $27.04 to $33.77 ph. Thisposition is eligible for anannual10%bonus opportunityin addition tothe base salary.

Outstanding Benefits and Perks:

We are proud to offer a varietyofbenefits that meet the diverse needs of our employees:

• Eligible forbenefitsthe 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 ofaccruedvacation time; accruals begin on Day 1
• Paid sick leave of48 hourspercalendar year
• Eligible employees may receive four (4) weeks paid Care Giver leave after 1 year of service orin accordance withstate 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

SDC: 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.

The Associate Quality Auditor plans, conducts, and reports on customer audits, internal quality audits and risk assessments across manufacturing, production, and process environments. This role ensures compliance with internal quality systems and applicable external regulations and standards, including GLP, GMP, ISO, and Six Sigma principles. Operating with supervision, the Associate Quality Auditor applies directed judgment to identify compliance gaps, assess risk, recommend corrective actions, and support continuous improvement initiatives.

Duties & Responsibilities

Audit Planning & Execution

• Plan, schedule, and conduct internal quality audits of manufacturing, production, and process controls.
• Develop audit plans, checklists, and sampling strategies based on applicable standards, historical performance, and risk profiles.
• Execute audits to assess compliance with internal procedures and external regulations (e.g., GLP, GMP, ISO).
• Identify nonconformances, trends, and systemic risks affecting product quality or regulatory compliance.

Reporting & Follow-Up

• Prepare clear, accurate, and well-structured written internal audit reports documenting observations, findings, and risk assessments.
• Communicate audit results to management and relevant stakeholders in a professional and constructive manner.
• Provide recommendations for corrective and preventive actions (CAPA) and support follow-up activities to verify effectiveness.
• Maintain audit documentation in accordance with quality system and record retention requirements.

External Audit Support

• Support and/or facilitate external audits conducted by customers, registrars, or regulatory bodies, as needed.
• Serve as a point of contact during on-site audit activities, providing documentation, clarification, and coordination.

Quality Systems & Continuous Improvement

• Contribute to the continuous improvement of audit processes, tools, and methodologies.
• Provide guidance to cross-functional teams on audit readiness, quality system expectations, and compliance best practices.
• Identify opportunities to reduce risk, improve controls, and strengthen overall quality system effectiveness.

Education & Experience

• Bachelor’s degree in Quality, Engineering, Life Sciences, or a related technical field required.
• 0-2 years of experience in quality assurance, quality auditing, or regulated manufacturing environments.

Knowledge, Skills & Abilities

• Knowledge of quality systems and regulatory standards (GLP, GMP, ISO, Six Sigma concepts).
• Ability to plan and conduct audits with guidance and sound professional judgment.
• Strong attention to detail.
• Ability to interpret regulations, standards, and internal procedures and apply them effectively.
• Effective collaboration skills with the ability to influence without authority.
• Proficiency with quality systems documentation and electronic quality management systems (eQMS).
• Ability to manage multiple audits and priorities with supervision.

Physical Demands (US Only)

• 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.

Qualifications

Skills

Behaviors

Motivations

Education

Experience

Licenses & Certifications

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.