Associate Quality Auditor

Are you looking for an opportunity to make a difference At Mesa Labswerepassionate 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: $27.04to$33.77 ph.

Thisposition is eligible for anannual10%bonus opportunityin addition tothe base salary.

Outstanding Benefits and Perks:

We are proud to offer a variety ofbenefits 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:

• Bachelors 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.
• 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.

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:

IC