Quality Assurance Engineer

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 potential bonus opportunities, equity awards, commission, and a comprehensive benefits package based on the position.

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

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 Quality Assurance Engineer to design, implement, and maintain comprehensive quality assurance protocols for our manufacturing operations. This role is critical to ensuring our production processes meet the highest standards of quality, safety, and regulatory compliance for worldwide distribution.

Duties/Responsibilities

• Quality System Design & Implementation

• Design, implement, and maintain quality assurance protocols and methods for processing materials into partially finished or finished products

• Develop methods and procedures for inspecting, testing, and evaluating the precision and accuracy of production processes, production equipment, and finished products

• Create and maintain quality documentation, standards, and procedures in accordance with industry best practices

• Compliance & Regulatory Management

• Plan, implement, and manage compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standards

• Ensure adherence to applicable standards and specifications (such as GLP, GMP, ISO, Six Sigma, or other relevant frameworks)

• Maintain current knowledge of regulatory requirements for worldwide distribution

• Support regulatory audits and inspections

• Documentation Control

• Review and approve critical quality documents, including test procedures, batch records, validation reports, and standard operating procedures (SOPs)

• Ensure documentation accuracy, completeness, and compliance with regulatory requirements

• Manage document revision control and version management systems

• Maintain document retention and archival practices in accordance with regulatory standards

• Corrective and Preventive Actions (CAPA)

• Investigate the root causes of non-conformances, product complaints, and quality issues

• Implement and verify effective corrective and preventive actions to address quality concerns

• Track and monitor CAPA effectiveness and closure

• Maintain comprehensive CAPA documentation and reporting systems

• Risk Management

• Identify and mitigate potential risks associated with products and processes

• Conduct and facilitate risk assessments using tools like Failure Mode and Effects Analysis (FMEA)

• Develop risk mitigation strategies and monitor their effectiveness

• Maintain risk management documentation and ensure integration with quality systems

• Quality Analysis & Continuous Improvement

• Perform comprehensive analysis of quality reports and production data to identify trends, patterns, and areas for improvement

• Recommend updates or changes to quality standards and procedures based on data-driven insights

• Lead or participate in root cause analysis and problem-solving initiatives

• Drive continuous improvement initiatives to enhance product quality and process efficiency

• Cross-Functional Collaboration

• Partner with R&D, product, production/operations teams and regulatory affairs to integrate quality requirements into all processes to resolve issues and maintain product quality.

• Provide technical guidance and training to production staff on quality procedures and standards

• Collaborate with suppliers and vendors on quality requirements and specifications

Experience/Education

• Bachelor's degree in life sciences, engineering, quality assurance, manufacturing, or related technical field
• 2 years of experience in manufacturing quality assurance or quality engineering

Knowledge and Skillsets

• Required:

• Strong knowledge of quality management systems and methodologies

• Experience with quality standards and regulations (GMP, ISO 13485, Six Sigma, or similar)

• Demonstrated ability to design and implement quality inspection and testing procedures

• Proven experience conducting root cause analysis and implementing CAPA

• Knowledge of risk management tools and methodologies, including FMEA

• Experience with documentation control systems and regulatory documentation requirements

• Proficiency in statistical analysis and quality metrics

• Excellent analytical and problem-solving skills

• Strong written and verbal communication skills

• Meticulous attention to detail and strong organizational skills

• Preferred:

• Advanced degree in biology, chemistry or engineering or related field

• Professional certifications (ASQ CQE, Six Sigma Black Belt, or similar)

• Experience in supporting quality assurance in life sciences consumables or medical device operations

• Knowledge of lean manufacturing principles

• Experience with quality management software and database systems

• Familiarity with design of experiments (DOE) and statistical process control (SPC)

• Experience with additional risk management methodologies (Hazard Analysis and Critical Control Points (HACCP), risk-based thinking, etc.)

• Experience with electronic document management systems (EDMS)

• Enter the environmental conditions in this section

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.