Senior Quality Auditor

Mesa Labs Career•Bozeman, MT

3d•$88,500 - $110,500

About The Position

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 potential bonus opportunities, equity awards, commission, and a comprehensive benefits package based on the position. This position supports Mesa's SDC business. Our 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 Senior Quality Auditor independently plans, conducts, and reports on 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 minimal supervision, the Senior Quality Auditor applies seasoned judgment to identify compliance gaps, assess risk, recommend corrective actions, and support continuous improvement initiatives. The role may also support external and supplier audits and serves as a knowledgeable resource to internal stakeholders on audit readiness and quality system compliance.

Requirements

Bachelor’s degree in Quality, Engineering, Life Sciences, or a related technical field required.
Typically 5+ years of experience in quality assurance, quality auditing, or regulated manufacturing environments.
Strong working knowledge of quality systems and regulatory standards (GLP, GMP, ISO, Six Sigma concepts).
Proven ability to independently plan and conduct audits with sound professional judgment.
Excellent written and verbal communication skills, including formal audit report writing.
Strong analytical and risk assessment skills with 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 minimal supervision.

Responsibilities

Audit Planning & Execution Plan, schedule, and conduct internal quality audits and risk assessments of manufacturing, production, and process controls. Managers customer audit program including scheduling, hosting and responding to customer audits. Develop audit plans, checklists, and sampling strategies based on applicable standards, historical performance, and risk profiles. Independently 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 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 & Supplier Audit Support Support and/or facilitate external audits conducted by customers, registrars, or regulatory bodies, as needed. Conduct or assist with vendor and supplier evaluation audits to assess qualification and ongoing compliance. 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.

Benefits

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
Flexible Time Off Policy
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