Quality Assurance Specialist III

Mesa Labs Career • Bozeman, MT

6d • Onsite

About The Position

The Quality Assurance Specialist III is responsible for leading and overseeing quality assurance and compliance activities within the Company. Develop and implement quality assurance strategies, ensuring adherence to regulatory standards, and providing expert guidance on complex compliance issues. The 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.

Requirements

• Bachelor's degree in Quality Management, Engineering, Life Science, or a related field.
• Minimum of 5 years of experience in Quality Assurance or related field.
• Deep knowledge of quality assurance principles, regulatory requirements, and industry standards.
• Proven track record of managing complex compliance projects and leading teams.
• Strong analytical and problem-solving skills.
• Excellent leadership, communication, and interpersonal skills.
• Ability to manage multiple high-priority projects simultaneously.
• Capacity to work independently and as part of a leadership team.
• Ability to navigate and influence in a fast-paced and dynamic environment.

Responsibilities

• Develop and implement comprehensive quality assurance and compliance strategies to ensure that products, services, and processes meet or exceed regulatory and quality standards.
• Lead complex audits of products, processes, and systems to assess compliance with internal standards and regulatory requirements. Oversee audit teams and manage audit schedules.
• Serve as the subject matter expert on regulatory requirements and industry standards. Ensure that the company remains compliant with all relevant regulations (e.g., FDA, ISO, GMP) and anticipate changes in regulatory landscapes.
• Identify and drive improvements in quality and compliance processes. Develop and implement strategic initiatives to enhance overall quality and operational efficiency.
• Evaluate and mitigate quality and compliance risks. Develop and oversee corrective and preventive action plans to address non-compliance and quality issues.
• Provide leadership and training to quality assurance teams and other departments. Mentor junior staff and foster a culture of continuous improvement and compliance excellence.
• Prepare and present detailed reports on quality metrics, audit findings, compliance status, and strategic recommendations to senior management and regulatory bodies.
• Collaborate with other departments (e.g., R&D, Manufacturing, Supply Chain) to integrate quality and compliance requirements into all stages of product development and delivery.

Benefits

• Competitive wages
• Bonus opportunity
• Comprehensive benefits package
• 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
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior