Quality Engineer

Quality EngineerAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.The Opportunity This position works out of our Santa Rosa, CA location in the Toxicology business within Abbott's Diagnostics Division. We're empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.The Quality Engineer will execute highly complex and specialized quality assurance projects supporting Abbott's Toxicology business, including clinical and forensic laboratory operations, drugs-of-abuse testing, quality systems compliance, and continuous improvement initiatives. This role applies advanced quality principles and analytical techniques to ensure compliance with applicable regulatory, accreditation, and quality standards. The Quality Engineer will serve as a key contributor to Quality Management System effectiveness, laboratory quality oversight, audit readiness, validation activities, process improvement, and regulatory compliance while partnering cross-functionally to deliver high-quality products and services that meet customer and business requirements.What You'll Work OnWorks on problems of diverse scopes and complexity where analysis of data, regulatory requirements, and considerable judgment and initiative are required to reach resolution or provide recommendations.Leads and/or contributes to quality system, test method, quality assurance, and operational process improvement projects.Supports and may administer Quality Management System processes including CAPA, document control, training, supplier quality, change control, management review, and quality metrics.Conducts complex analysis of quality records, laboratory data, audit findings, investigations, trends, and reports to identify opportunities for continuous improvement.Supports equipment, process, facility, software, and test method qualification, validation, verification, and change control activities.Conducts inspection, verification, and validation of components, materials, systems, and processes used in development, laboratory, and manufacturing activities.Conducts and supports internal audits and external inspections, including CLIA and CAP, customer, and supplier audits, and ensures timely implementation of corrections and corrective actions.Identifies and addresses recurring quality, compliance, and operational issues impacting product quality, laboratory testing, data integrity, or regulatory compliance.Develops, tracks, analyzes, and trends quality metrics and key performance indicators and communicates results to management.Documents quality issues, investigations, nonconformances, CAPAs, effectiveness checks, and performance measures for management review.Required QualificationsBS/BA degree or equivalent in chemistry, biology, or other scientific discipline or equivalent experience.Minimum of five to eight years of Quality Assurance experience in a regulated FDA medical device manufacturing environment or ISO certified laboratory, with 3-5 years progressively responsible positions.Experience implementing, leading, or coordinating electronic document controls or CAPA program, including practical application of root cause analysis tools.Thorough knowledge and experience implementing quality Systems Regulations ISO 17025,13485, CLIA, or 21 CFR 820.Preferred QualificationsProven experience leading and maintaining Quality Management Systems (QMS), including CAPA, audits, document control, training, change control, nonconformance management, management review, and continuous improvement programs.Regulatory & Compliance Knowledge: Strong understanding of CLIA, CAP accreditation requirements, laboratory quality systems, data integrity, quality control, proficiency testing, and applicable state and federal regulations.Technical & Analytical Capabilities: Experience with root cause analysis, risk assessment, method validation/verification, equipment qualification, quality metrics, KPI reporting, internal audits, and regulatory inspection readiness.Leadership & Communication Skills: Excellent technical writing, problem-solving, organizational, and cross-functional collaboration skills, with proficiency in eQMS platforms, document management systems, LMS tools, and Microsoft Office applications.The base pay for this position is $90,000.00 – $180,000.00. In specific locations, the pay range may vary from the range posted.