Quality Assurance Specialist III

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 bonus opportunity, and a comprehensive benefits package.

Base Compensation Range: $24.16 / hour - $30.17 / hour

This position is eligible for an annual 10% bonus opportunity in addition to the base salary

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

• 3 weeks of accrued vacation time; accruals begin on Day 1

• 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
• Overtime opportunities

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

We are seeking a detail-oriented Quality Assurance Specialist representative to join our manufacturing organization. This role provides essential support for our Quality Assurance functions, ensuring our products and processes meet both company standards and regulatory requirements as well as ensuring customer satisfaction.

Duties/Responsibilities

Quality Assurance Support

• Support quality assurance activities including monitoring QA Help and Bozeman complaint email inboxes, audits, document control, and compliance verification.
• Help maintain and monitor quality documentation, records, and reporting systems.
• Participate in the implementation of quality standards, objectives, and procedures.
• Support root cause analysis and corrective action processes as assigned.

Documentation & Compliance

• Maintain accurate quality records in accordance with firm and regulatory requirements.
• Assist with preparation of quality reports, metrics, and performance indicators.
• Support documentation review and control processes.
• Help ensure compliance with industry standards and regulatory guidelines.

Process Support

• Support quality improvement initiatives and continuous improvement projects.
• Participate in internal and external audit activities.
• Collaborate with production, engineering, and supply chain teams on quality matters.
• Help identify and communicate quality issues or non-conformances.

Additional Duties

• Perform other quality-related tasks and projects assigned by management.
• Support training activities related to quality procedures and standards.

Experience/Education

Required

• High school diploma or equivalent
• Minimum of 5 years of relevant experience in a quality or manufacturing environment
• Understanding of quality control principles and basic statistical methods
• Strong attention to detail and commitment to accuracy
• Proficient computer skills including Microsoft Office applications.
• Ability to read and interpret technical documents, drawings, and specifications.
• Excellent communication skills, both written and verbal

Preferred

• Associate's degree in quality, manufacturing, or related field preferred
• Knowledge of quality management systems (ISO 13485, 21CFR 820, or similar)
• Experience with root cause analysis methodologies (5 Why, Fishbone)
• Understanding of regulatory requirements relevant to our industry

Physical Demands:

• 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: May require standing, walking, and occasional lifting up to 25 lbs.
• Repetitive motions: Frequent use of keyboard and mouse.

Environmental Conditions:

• Manufacturing environment with exposure to production floor operations
• Use of personal protective equipment (PPE) as required.
• Standard business hours with flexibility for production needs
• 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.