Senior Quality Auditor

Are you looking for an opportunity to make a difference At Mesa Labs were 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.

Base Compensation Range: $88500 $110500
*In addition you qualify for:

• Annual bonus opportunity of 12% based on company performance
• Annual equity award of $10000

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

• 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

This position supports Mesas 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.

Duties & 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.

Education & Experience

• Bachelors 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.

Knowledge Skills & Abilities

• 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.

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.

Required Experience:

Senior IC