Quality Assurance Engineer

Overview

Design and implement QA protocols for manufacturing, ensuring compliance and quality.

Key Responsibilities

• capa management
• risk assessment
• documentation control
• quality analysis
• regulatory compliance
• continuous improvement

Tasks

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. -Identify and mitigate potential risks associated with products and processes -Implement and verify effective corrective and preventive actions to address quality concerns -Support regulatory audits and inspections -Provide technical guidance and training to production staff on quality procedures and standards -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. -Corrective and Preventive Actions (CAPA) Investigate the root causes of non-conformances, product complaints, and quality issuesImplement and verify effective corrective and preventive actions to address quality concernsTrack and monitor CAPA effectiveness and closureMaintain comprehensive CAPA documentation and reporting systems -Develop risk mitigation strategies and monitor their effectiveness -Maintain document retention and archival practices in accordance with regulatory standards -Create and maintain quality documentation, standards, and procedures in accordance with industry best practices -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 requirementsManage document revision control and version management systemsMaintain document retention and archival practices in accordance with regulatory standards -Plan, implement, and manage compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standards -Risk Management Identify and mitigate potential risks associated with products and processesConduct and facilitate risk assessments using tools like Failure Mode and Effects Analysis (FMEA)Develop risk mitigation strategies and monitor their effectivenessMaintain risk management documentation and ensure integration with quality systems -Maintain comprehensive CAPA documentation and reporting systems -Maintain risk management documentation and ensure integration with quality systems -Maintain current knowledge of regulatory requirements for worldwide distribution -Ensure adherence to applicable standards and specifications (such as GLP, GMP, ISO, Six Sigma, or other relevant frameworks) -Quality Analysis & Continuous Improvement Perform comprehensive analysis of quality reports and production data to identify trends, patterns, and areas for improvementRecommend updates or changes to quality standards and procedures based on data-driven insightsLead or participate in root cause analysis and problem-solving initiativesDrive continuous improvement initiatives to enhance product quality and process efficiency -Collaborate with suppliers and vendors on quality requirements and specifications -Ensure documentation accuracy, completeness, and compliance with regulatory requirements -Manage document revision control and version management systems -Enter the environmental conditions in this section -Track and monitor CAPA effectiveness and closure -Develop methods and procedures for inspecting, testing, and evaluating the precision and accuracy of production processes, production equipment, and finished products -Design, implement, and maintain quality assurance protocols and methods for processing materials into partially finished or finished products -Compliance & Regulatory Management Plan, implement, and manage compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standardsEnsure 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 distributionSupport regulatory audits and inspections -Review and approve critical quality documents, including test procedures, batch records, validation reports, and standard operating procedures (SOPs) -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 -Investigate the root causes of non-conformances, product complaints, and quality issues -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 standardsCollaborate with suppliers and vendors on quality requirements and specifications -Conduct and facilitate risk assessments using tools like Failure Mode and Effects Analysis (FMEA) -Quality System Design & Implementation Design, implement, and maintain quality assurance protocols and methods for processing materials into partially finished or finished productsDevelop methods and procedures for inspecting, testing, and evaluating the precision and accuracy of production processes, production equipment, and finished productsCreate and maintain quality documentation, standards, and procedures in accordance with industry best practices -Perform comprehensive analysis of quality reports and production data to identify trends, patterns, and areas for improvement

Requirements

• gmp
• iso 13485
• fmea
• six sigma
• asq cqe
• lean manufacturing

What You Bring

-Experience with additional risk management methodologies (Hazard Analysis and Critical Control Points (HACCP), risk-based thinking, etc.) -Proven experience conducting root cause analysis and implementing CAPA -Experience with quality standards and regulations (GMP, ISO 13485, Six Sigma, or similar) -Knowledge of risk management tools and methodologies, including FMEA -Experience with quality management software and database systems -Bachelor's degree in life sciences, engineering, quality assurance, manufacturing, or related technical field -Required:Strong knowledge of quality management systems and methodologiesExperience with quality standards and regulations (GMP, ISO 13485, Six Sigma, or similar)Demonstrated ability to design and implement quality inspection and testing proceduresProven experience conducting root cause analysis and implementing CAPAKnowledge of risk management tools and methodologies, including FMEAExperience with documentation control systems and regulatory documentation requirementsProficiency in statistical analysis and quality metricsExcellent analytical and problem-solving skillsStrong written and verbal communication skillsMeticulous attention to detail and strong organizational skills -Excellent analytical and problem-solving skills -Strong written and verbal communication skills -Strong knowledge of quality management systems and methodologies -2 years of experience in manufacturing quality assurance or quality engineering -Meticulous attention to detail and strong organizational skills -Advanced degree in biology, chemistry or engineering or related field -Experience in supporting quality assurance in life sciences consumables or medical device operations -Knowledge of lean manufacturing principles -Familiarity with design of experiments (DOE) and statistical process control (SPC) -Demonstrated ability to design and implement quality inspection and testing procedures -Experience with documentation control systems and regulatory documentation requirements -Experience with electronic document management systems (EDMS) -Professional certifications (ASQ CQE, Six Sigma Black Belt, or similar) -Proficiency in statistical analysis and quality metrics -Preferred:Advanced degree in biology, chemistry or engineering or related fieldProfessional certifications (ASQ CQE, Six Sigma Black Belt, or similar)Experience in supporting quality assurance in life sciences consumables or medical device operationsKnowledge of lean manufacturing principlesExperience with quality management software and database systemsFamiliarity 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

People Also Searched For

Benefits

At Mesa Labs we offer competitive wages, including potential bonus opportunities, equity awards, commission, and a comprehensive benefits package based on the position. -Company paid short term and long-term disability (unless covered by a state disability plan) -Tiered Medical, Dental and Vision Insurance options, Health savings (HSA), healthcare & dependent care flexible spending (FSA) accounts -Eligible for benefits the first day of the month after you start -Company paid life insurance and AD&D -Nine (9) paid company holidays per year -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 -Eligible employees may receive four (4) weeks paid Care Giver leave after 1 year of service or in accordance with state leave laws -Flexible Time Off Policy -Paid sick leave of 48 hours per calendar year

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

Security Clearance

-criminal background checks are conducted upon offer acceptance.