Senior Quality Engineer

Senior Quality Engineer (CAPA / QMS Focus)Location: Twin Cities, MNFull-time | OnsitePosition SummaryWe are seeking an experienced and detail-oriented Senior Quality Engineer to drive continuous improvement across our Quality Management System (QMS). This role will lead and manage Corrective and Preventive Actions (CAPAs), oversee Nonconformance Reports (NCRs), conduct in-depth root cause analyses, and ensure ongoing compliance with regulatory and internal quality standards.This role requires a highly hands-on, self-directed engineer comfortable managing multiple CAPAs simultaneously in a small-team environment, with experience in complaint investigations, NCMR processes, and supporting quality activities for clinical-stage or Class II/III medical devices (PMA experience a plus).Key ResponsibilitiesCAPA ManagementLead end-to-end CAPA processes, including initiation, investigation, implementation, and effectiveness verificationEnsure timely closure of CAPAs in compliance with internal procedures and regulatory requirementsIdentify systemic issues and recommend preventative actions across the organizationTrack and trend CAPA data to drive continuous improvement initiativesNonconformance (NCR) OversightReview, disposition, and manage Nonconformance Reports (NCRs)Collaborate cross-functionally to assess impact and determine appropriate actionsEnsure accurate documentation and traceability of nonconformance handlingAnalyze NCR trends to identify recurring issues and improvement opportunitiesRoot Cause AnalysisConduct and facilitate structured root cause investigations (e.g., 5 Whys, Fishbone, Fault Tree Analysis)Drive cross-functional problem-solving efforts for complex quality issuesEnsure root cause identification is data-driven, thorough, and sustainableCoach teams on effective problem-solving methodologiesQuality Management System (QMS) MaintenanceSupport the development, implementation, and continuous improvement of the QMSEnsure compliance with applicable standards (e.g., ISO 9001, ISO 13485, AS9100, or industry-specific regulations)Lead internal audits and support external regulatory audits and inspectionsMaintain and improve quality procedures, work instructions, and documentationMonitor key quality metrics and report on system effectivenessContinuous ImprovementDrive initiatives that improve product quality, reduce defects, and enhance process efficiencyUtilize data analysis and quality tools (e.g., SPC, Pareto analysis) to identify improvement areasPartner with engineering, manufacturing, and operations teams to implement solutionsQualificationsRequiredBachelor's degree in Engineering, Quality, or related technical field5-8+ years of Quality Engineering experience in a regulated industry (e.g., medical device, aerospace, manufacturing)Deep experience with CAPA and NCR systemsStrong expertise in root cause analysis methodologiesHands-on experience maintaining and improving a Quality Management System (QMS)Working knowledge of relevant industry standards (ISO, FDA, or equivalent)Excellent problem-solving, analytical, and organizational skillsPreferredASQ certifications (e.g., CQE, CQA)Experience with electronic QMS (eQMS) platformsLean Six Sigma (Green Belt or Black Belt)Experience supporting audits and regulatory inspectionsKey CompetenciesStructured problem-solving and investigative mindsetStrong attention to detail and documentation disciplineAbility to influence cross-functional teamsData-driven decision-makingContinuous improvement orientationWhy Join UsOpportunity to shape and strengthen quality systems at a strategic levelHigh visibility role with cross-functional collaborationDynamic environment focused on innovation and excellenceEOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.To find out more about Real, please visit