Associate Quality Auditor

Mesa Labs Career•Bozeman, MT

4d•Onsite

About The Position

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.

Requirements

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 of quality systems and regulatory standards (GLP, GMP, ISO, Six Sigma concepts).
Ability to plan and conduct audits with guidance and sound professional judgment.
Excellent verbal communication skills.
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.

Responsibilities

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.
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.
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.
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.

Benefits

Competitive wages
Bonus opportunity
Comprehensive benefits package
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
Company paid life insurance and AD&D
3 weeks of accrued vacation time
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
Employee Wellness and Financial Assistance Resources through Cigna and NY Life
Nine (9) paid company holidays per year
Overtime opportunities