Quality Assurance Specialist III

Mesa Laboratories, Inc.

The Role

Overview

Support QA activities, documentation, compliance, and continuous improvement in manufacturing.

Key Responsibilities

  • document control
  • quality reporting
  • audit support
  • root cause
  • compliance
  • continuous improvement

Tasks

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. -Support documentation review and control processes. -Assist with preparation of quality reports, metrics, and performance indicators. -Collaborate with production, engineering, and supply chain teams on quality matters. -Participate in internal and external audit activities. -Help maintain and monitor quality documentation, records, and reporting systems. -Help identify and communicate quality issues or non-conformances. -Using computers: Typing and using office equipment. -Support root cause analysis and corrective action processes as assigned. -Help ensure compliance with industry standards and regulatory guidelines. -Support quality improvement initiatives and continuous improvement projects. -Use of personal protective equipment (PPE) as required. -Participate in the implementation of quality standards, objectives, and procedures. -Noise Levels: The noise level is moderate, with occasional interruptions from phone calls and conversations. Use non-canceling headphones if necessary. -Support quality assurance activities including monitoring QA Help and Bozeman complaint email inboxes, audits, document control, and compliance verification. -Support training activities related to quality procedures and standards. -Maintain accurate quality records in accordance with firm and regulatory requirements.

Requirements

  • associate degree
  • 5 years
  • iso 13485
  • microsoft office
  • root cause
  • statistical

What You Bring

-Associate’s degree in quality, manufacturing, or related field preferred -Repetitive motions: Frequent use of keyboard and mouse. -Ergonomics: Workstations with desk and adjustable chairs to support good postures. -Standing or walking: Occasionally for meetings or office tasks. -Lifting: May require standing, walking, and occasional lifting up to 25 lbs. -Strong attention to detail and commitment to accuracy -Ability to read and interpret technical documents, drawings, and specifications. -Proficient computer skills including Microsoft Office applications. -Understanding of regulatory requirements relevant to our industry -Experience with root cause analysis methodologies (5 Why, Fishbone) -Ventilation: Good ventilation to ensure a comfortable working environment, though this can vary depending on the building. -High school diploma or equivalent -Minimum of 5 years of relevant experience in a quality or manufacturing environment -Excellent communication skills, both written and verbal -Lighting: Adjustable lighting to reduce eye strain. -Knowledge of quality management systems (ISO 13485, 21CFR 820, or similar) -Understanding of quality control principles and basic statistical methods

Benefits

At Mesa Labs we offer competitive wages, including bonus opportunity, and a comprehensive benefits package. Base Compensation Range: $24.16 / hour - $30.17 / hourThis position is eligible for an annual 10% bonus opportunity in addition to the base salary -Nine (9) paid company holidays per year -Company paid life insurance and AD&D -Eligible for benefits the first day of the month after you start -Tiered Medical, Dental and Vision Insurance options -3 weeks of accrued vacation time; accruals begin on Day 1 -Health savings (HSA), healthcare & dependent care flexible spending (FSA) accounts -401(k) plan that provides a 4% Safe Harbor company match on a 4% employee contribution that begins on Day 1 -Eligible employees may receive four (4) weeks paid Care Giver leave after 1 year of service or in accordance with state leave laws -Employee Wellness and Financial Assistance Resources through Cigna and NY Life -Overtime opportunities -Paid sick leave of 48 hours per calendar year -Standard business hours with flexibility for production needs -Company paid short term and long-term disability (unless covered by a state disability plan)

The Company

About Mesa Laboratories, Inc.

-is a global leader in providing high-quality scientific instruments and services. -specializes in solutions for testing and monitoring critical systems. -offers a range of innovative products, from bioprocessing and quality assurance to laboratory testing. -is a trusted partner for pharmaceutical, biotechnology, and healthcare industries. -diverse portfolio includes calibration equipment, biological indicators, and sterilization monitoring. -works on a global scale, supporting industries that rely on precision and compliance with rigorous standards. -has been a pioneer in the development of automated testing and monitoring systems. -has experienced consistent growth, expanding into new international markets with ease. -is particularly known for its leadership in the healthcare and life sciences sectors.

Sector Specialisms

Pharmaceutical

Healthcare

Manufacturing

Service

Dental

Medical Device

Food and Beverage

Industrial Hygiene

Environmental Air Sampling

Biopharmaceutical Development

Security Clearance

-criminal background checks are conducted upon offer acceptance.